[Federal Register Volume 60, Number 237 (Monday, December 11, 1995)] [Rules and Regulations] [Pages 63578-63606] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-29906] [[Page 63577]] _______________________________________________________________________ Part II Department of Health and Human Services _______________________________________________________________________ Food and Drug Administration _______________________________________________________________________ 21 CFR Part 803, et al. Medical Device User Facility and Manufacturer Reporting, Certification and Registration; Delegations of Authority; Medical Device Reporting Procedures; Final Rules Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations ======================================================================= ----------------------------------------------------------------------- [[Page 63578]] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 803 and 807 [Docket No. 91N-0295] RIN 0910-AA09 Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; opportunity for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is issuing regulations requiring medical device user facilities and manufacturers to report adverse events, related to medical devices, under a uniform reporting system. This regulation is mandated by the Safe Medical Devices Act of 1990 (SMDA) and prescribes the conditions under which reports must be submitted, the content and timing of the requisite reports, and how FDA will utilize the information in carrying out its public health protection responsibilities. This rule is intended to augment the agency's postmarket surveillance activities and public health protection responsibilities relating to medical devices. In the future, FDA will propose to revoke the distributor adverse event reporting regulations that went into effect on May 28, 1992, by operation of law and replace them with provisions based on notice and comment. FDA will also propose to fully implement its authority under the Medical Device Amendments of 1992 (the 1992 amendments). DATES: This final rule is effective April 11, 1996. Submit written comments, as requested elsewhere in this document by, January 10, 1996. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Earl W. Robinson, Center for Devices and Radiological Health (HFZ-530), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-2735. SUPPLEMENTARY INFORMATION: On November 26, 1991 (56 FR 60024), FDA published a tentative final rule implementing the user and distributor reporting provisions of the SMDA (hereinafter referred to as the November 1991 tentative final rule). The agency received over 300 comments in response to the tentative final rule, which are carefully evaluated and responded to in this final rule. The final rule also reflects the superseding reporting standard mandated by the Medical Device Amendments of 1992. I. Highlights of the Final Rule This final rule provides FDA with increased post-market surveillance information by requiring medical device user facilities and manufacturers to report adverse event information as follows: (a) Medical device user facilities must submit a medical device report (MDR) to the device manufacturer within 10 days after becoming aware of a reportable death or serious injury (including serious illness). If the event involves a device-related death, or if the identity of the device manufacturer is not known, the report must be sent to FDA. User facilities must also submit a semiannual summary of reports to FDA. (b) Device manufacturers must submit MDR reports to FDA within 30 days after becoming aware of a reportable death, serious injury, or malfunction. (c) Device manufacturers must annually certify the number of MDR reports filed with FDA during the preceding year. (d) Upon receiving information about an MDR reportable event, device manufacturers must submit a ``5-day report'' to FDA, within 5 work days of: (1) Becoming aware that a reportable event or events, from any information, including any trend analysis, necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health; or (2) becoming aware of an MDR reportable event from which FDA has made a written request for the submission of a 5-day report. (e) A device manufacturer is responsible for reporting MDR events related to its devices, whether or not the devices are still being marketed by the firm. If a manufacturer receives information about an event involving a device incorrectly identified as one marketed by that firm, the information received must still be forwarded to FDA, with an explanation that the device was misidentified. In finalizing this regulation, FDA has worked to meet the significant challenges of devising an effective medical device adverse event reporting system while balancing industry concerns with public health needs and statutory imperatives. The agency has also taken steps to minimize the administrative costs and paperwork burdens that will inevitably result for FDA, the medical device industry, and the device user community. FDA is keenly aware of and sensitive to the impacts of these new regulatory requirements on the pace of technological advancement and economic well-being of the medical device industry. At the same time, the agency is cognizant of the usefulness of information about the clinical performance of medical devices in fulfilling its public health mandate. In striving to achieve regulatory balance, the agency carefully analyzed over 300 public comments submitted in response to the November 1991 tentative final rule, and resolved policy and legal issues arising from the comments and internal deliberations. This review of comments, combined with an economic threshold analysis, and other agency studies and deliberations, resulted in a number of major modifications that will facilitate compliance with the final reporting requirements and substantially reduce the overall costs, by an estimated $31 million, borne by device user facilities, the device industry, and the agency. These modifications are as follows: (a) The agency has eliminated certain criteria from the previously proposed manufacturer monthly reports including: An evaluation consisting of a narrative description of the results of statistical trend analyses conducted by the manufacturer, a discussion of the underlying methodologies used, a description of any unusual or unexpected events, and a description of any remedial actions taken. FDA believes that the benefits of the proposed mandatory trend analyses were not commensurate with the attendant costs to industry. Upon further review, the agency has determined that it would incur the costs of data entry regardless of the industry's analysis, and operating a computer program for the analysis of the data would be a relatively low cost to the agency. The proposed requirements for other information that the final regulation is not adopting will still be made available to the agency under the existing current good manufacturing practice (CGMP) regulations (21 CFR part 820), and under proposed 21 CFR part 806, reports of removals and corrections (59 FR 13828, March 23, 1994). (b) The final regulation's reporting timeframe is shorter than the timeframe proposed. Earlier access to adverse event information will help the agency better to protect the public health. (c) The agency has eliminated the proposed training and educational requirements, which would have been particularly costly to user facilities, [[Page 63579]] because the projected costs substantially exceeded expected benefits. This change will provide a net estimated annual cost saving of $29.1 million. (d) The proposed imminent hazard report deadline has been extended from 3 days to 5 days, and renamed a 5-day report. This extended reporting timeframe should provide a more realistic opportunity for the manufacturer to conduct a preliminary investigation regarding the event. Any information not available for submission on the 5-day report must be submitted in a supplemental report. (e) The agency has developed reporting forms for baseline reports, semiannual reports, and annual certifications. This action will streamline the reporting procedure because industry will not be required to format its own reports. The standardized report forms and associated standardized electronic reporting formats will facilitate the input of information submitted into FDA's data base. This more efficient data processing will increase the agency's capacity to respond to critical device- related problems by permitting more rapid data analysis, leading to appropriate corrective measures. (f) The agency has adapted its MDR systems and reporting requirements in order to use the MEDWATCH form for reporting individual adverse events. In so doing, FDA has eliminated a number of proposed reporting elements, including the ``degree of certainty'' associated with a reportable event, the ``medical status of patients'' involved in device-related incidents, product ``service and maintenance,'' etc. The adoption of the MEDWATCH reporting form streamlines the reporting process and reduces the amount of information reporters must submit to FDA. (g) The agency has clarified that user facilities must report only information that is reasonably known to them, and are not required to investigate adverse events. (h) The agency has devoted much time and effort to accommodate electronic reporting. The agency is in the process of developing formats, guidelines, and procedures for electronic reports which, when available, will obviate the need for written agency approval for the use of electronic submissions. (i) In response to comments, the agency has clarified a number of the definitions included in the proposed rule and added new definitions to enhance clarity. The agency also substantially altered the organization and the paragraph designations of the final rule to provide information in the clearest and most usable form in part 803 (21 CFR part 803). Revised part 803 has been subdivided into five subparts. Subpart A contains general provisions including sections for the scope, definitions, public availability of reports, and general reporting and record requirements. Subpart B of revised part 803 contains generally applicable reporting requirements for individual adverse event reports. Specific requirements for individual adverse event reports, and other reports required by user facilities and manufacturers, are in subparts C and E, respectively. Each subpart divides the reporting requirements for each type of reporting entity into separate sections that are organized to improve readability. The agency believes that the new organization of the regulation provides clearer guidance to industry than the 1991 tentative final rule. II. Background Under the Federal Food, Drug, and Cosmetic Act of 1938 (21 U.S.C. 301-394) (the act), and the Medical Device Amendments of 1976 (Pub. L. 94-295) (the 1976 amendments), FDA issued medical device reporting regulations for manufacturers (49 FR 36326 at 36348, September 14, 1984). To correct weaknesses noted in the 1976 amendments, and to better protect the public health by increasing reports of device- related adverse events, Congress enacted the SMDA (Pub. L. 101-629), which required medical device user facilities, and distributors to report certain device-related adverse events. In response to a directive in the SMDA, FDA issued the November 1991 tentative final rule proposing to implement regulations concerning reporting of adverse events related to devices by user facilities and distributors. In the November 1991 tentative final rule, FDA also proposed to amend the existing manufacturer reporting regulations to conform to the proposed user facility and distributor reporting requirements. A. User Facility, Manufacturer and Distributor Reporting Requirements Under the SMDA The SMDA added section 519(b)(1) to the act (21 U.S.C. 360i(b)(1)) to require that certain user facilities (hospitals, nursing homes, ambulatory surgical facilities and outpatient treatment facilities) report certain adverse events. The SMDA also authorized FDA to require diagnostic outpatient facilities to submit reports. Under the SMDA, user facilities must report device-related deaths to FDA and to the manufacturer. They must also report serious illnesses and injuries to the manufacturer, or to FDA if the manufacturer's identity is unknown. Reports must be made as soon as practicable, but no later than 10 working days after the user facility becomes aware of a reportable event. In addition to individual adverse event reports, the SMDA requires each user facility to submit to FDA, on a semiannual basis, a summary of the reports it has submitted to FDA and to manufacturers. The provision in section 519(b) of the act that requires user facilities to report adverse events became effective by operation of law on November 28, 1991. In addition to requiring reporting by user facilities, the SMDA added section 519(a)(6) (subsequently redesignated as 519(a)(9) by the 1992 amendments) to the act to require FDA to issue regulations regarding distributor reporting of adverse device events. The SMDA also added section 519(d) to the act to require both manufacturers and distributors to certify to FDA either the number of reports submitted in a year or that no such reports were submitted to the agency. Distributor reporting requirements became effective on May 28, 1992, when the provisions relating to distributor reporting in the November 1991 tentative final rule became final by operation of law. In the Federal Register of September 1, 1993 (58 FR 46514), FDA published a notice announcing that the proposed distributor reporting regulations had become final by operation of law on May 28, 1992, and that these regulations had been amended by certain provisions of the 1992 amendments discussed below. In the Federal Register of September 1, 1993, FDA also published a final rule, based on the November 1991 tentative final rule, requiring distributors to register and list their devices (58 FR 46514). Distributor registration and listing requirements became effective on October 1, 1993. In a future rulemaking, FDA will propose in the Federal Register to revoke the distributor regulation that went into effect by operation of law and replace it with provisions based on notice and comment. B. User Facility, Manufacturer and Distributor Reporting Requirements Under the Medical Device Amendments of 1992 Subsequent to FDA's issuance of the November 1991 tentative final rule to require adverse event reporting by user facilities, distributors, and manufacturers, on June 16, 1992, the President signed into law the 1992 [[Page 63580]] amendments (Pub. L. 102-300), amending certain provisions of section 519 of the act relating to reporting of adverse device events. In the future, FDA will publish a proposed rule to fully implement its authority under the 1992 amendments. A summary of these changes follows: 1. Adoption of a Single Reporting Standard Section 5(a) of the 1992 amendments adopts a single standard to specify when injuries caused by devices must be reported to FDA. Manufacturers and importers are required to report a device-related adverse event to FDA whenever they receive or otherwise become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and that such device or a similar device marketed by them would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Similarly, section 5(a) of the 1992 amendments revises the reporting requirements to require a user facility to report whenever the facility receives or otherwise becomes aware of information that reasonably suggests that a device ``has or may have caused or contributed'' to the death, serious illness or serious injury of a patient of the facility. 2. Single Definition of Types of Injuries That Must Be Reported Section 5(a) of the 1992 amendments also adopted a single definition for the types of injuries that user facilities, manufacturers, importers, and distributors must report. This definition requires reporting of an injury or illness that is: (1) Life- threatening; (2) results in permanent impairment of a body function or permanent damage to a body structure; or (3) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. This definition differs from the previous statutory definition of ``serious injury'' or ``serious illness'' in the user facility provisions and the definition in the November 1991 tentative final regulation. The new definition deleted the requirement that an injury must require immediate intervention to preclude permanent impairment or damage in order to qualify as a reportable adverse event. 3. New Authority To Require Reporting of ``Other Significant Adverse Device Experiences'' The 1992 amendments also authorized FDA to issue regulations requiring user facilities, manufacturers, importers, and distributors to report ``significant adverse device experiences'' that the agency determines are necessary to be reported, other than deaths, serious injuries or serious illnesses, that might otherwise not fall within the definitions of reportable deaths, serious injuries, or malfunctions. III. Reporting Forms A. Individual Adverse Event Reports by User Facilities and Manufacturers Under Secs. 803.30 and 803.50, user facilities and manufacturers are required to submit device-related reports of individual adverse events on FDA Form 3500A or an FDA approved electronic equivalent. In order to simplify and consolidate reporting of adverse events, FDA announced in the Federal Register of February 26, 1993 (58 FR 11768) the availability of a new single ``MEDWATCH'' form for reporting adverse events and product problems with devices, drugs, biologics, special nutritional products and other products regulated by the agency (hereinafter referred to as the February 1993 notice). In response to FDA's request for comments on the form in the Federal Register, 79 comments were submitted by medical device trade associations and other regulated or affected entities. On June 3, 1993 (58 FR 31596), after consideration of these comments, FDA published the final reporting form. (The form is described in Sec. 803.10.) B. Annual Certification by Manufacturers Under Sec. 803.57, manufacturers must also submit at the time of their annual registration a completed FDA Form 3381 or an FDA approved electronic equivalent, certifying: (1) That all reportable events were submitted; (2) the number of reports submitted; or (3) that no reports were submitted during the previous 12-month period. C. Semiannual Summaries by User Facilities Under Sec. 803.33, user facilities are required to submit, on FDA Form 3419 or an FDA approved electronic equivalent, a semiannual summary of all events reported during the prior reporting period. Semiannual reports must include information regarding the user facility, device manufacturers, products, and a brief description of the events. D. Baseline Reports Under Sec. 803.55, manufacturers must submit baseline reports, on FDA Form 3417 or an FDA approved electronic equivalent, simultaneously with the submission of the first event report for each device. These reports, which are to be updated annually, must contain information on the manufacture and distribution of the relevant devices. E. Effective Date of the Reports Adverse event reports and other related reports required by this regulation must be submitted using the appropriate forms or approved electronic equivalents, after April 11, 1996. IV. Summary and Analysis of Comments and FDA's Response This final rule is based on FDA's analysis of the over 300 comments that the agency received in response to the November 1991 tentative final rule, and it conforms to certain statutory revisions in the 1992 amendments. This final rule reflects actions in two areas. First, it revises the manufacturer reporting regulations that have been in effect since 1984. Second, it implements the statutorily directed user facility reporting requirements that have been in effect since November 28, 1991. Originally, FDA gave interested persons until January 27, 1992, to comment on the November 1991 tentative final rule. In the Federal Register of January 24, 1992 (57 FR 2861), FDA extended the comment period until February 26, 1992. A summary of the comments and FDA's responses follow: A. Section 803.1--Scope 1. Several comments stated that the proposed regulation exceeds the SMDA and has no statutory authority. Many comments stated that the scope of the provisions was overly broad, and would increase the burdens, with unclear benefits, on all parties involved. The agency disagrees. Section 519 of the act, as amended by the SMDA and the 1992 amendments, provides clear authority to issue this regulation. Section 519 of the 1976 amendments granted FDA the authority to issue regulations to require manufacturers to maintain such records, make such reports, and provide such information to FDA as may reasonably be necessary to ensure that devices are not adulterated or misbranded and are otherwise safe and effective for human use. The legislative history of the 1976 [[Page 63581]] amendments reflects clear congressional intent to permit FDA to require, under the authority of section 519 of the act, manufacturers to report to FDA product defects and adverse effects of the firms' devices. (See H. Rept. 853, 94th Cong., 2d Sess. 23 (1976).) Among other things, section 519 of the act states that any reporting requirement established under the authority of that section: (1) May not be unduly burdensome (considering the cost of compliance and the need for the requirement); (2) shall state the purpose for any required report or information and identify to the fullest extent practicable such report or information; (3) may not, except in certain circumstances, require the disclosure of a patient's identity; and (4) may not, except in certain circumstances, require the manufacturer of a class I device to maintain records or to submit information not in its possession, unless such report or information is necessary to determine whether a device is misbranded or adulterated. The House Report cautions, however, that these limitations ``should not be construed as limiting the Secretary's authority to obtain information needed to insure that the public is protected from potentially hazardous devices.'' (Id.) In its discussion of section 519 of the act, the House Report lists examples of reasonable reporting requirements, including reports of defects, adverse reactions and patient injuries. It is also clear from the legislative history that Congress intended FDA to use its authority under section 519 of the act to protect the public from potentially hazardous devices, as well as from devices with confirmed hazards. (Id.) Since enactment of the 1976 amendments, Congress has focused considerable attention on FDA's implementation and enforcement of the act. Congress concluded that the 1976 amendments were not always adequate to protect the public health. (H. Rept. 808, 101st Cong., 2d Sess. 13-14 (1990); S. Rept. 513, 101st Cong., 2d Sess. 13-16 (1990).) To correct these problems, Congress passed and the President, on November 28, 1990, signed into law the SMDA, which amended the medical device provisions of the act. The SMDA added section 519(b)(1) to the act to require that certain user facilities (e.g., hospitals, nursing homes, ambulatory surgical facilities, and outpatient treatment facilities) report deaths related to medical devices to FDA, as well as to the manufacturer if the manufacturer's identity is known. Section 519(b)(5)(A) of the act also provides FDA with authority, which FDA has exercised in this final regulation, to include outpatient diagnostic facilities in this requirement. Serious illnesses and injuries are to be reported to the manufacturer, or to FDA if the manufacturer's identity is not known. Reports must be made as soon as practicable but no later than 10 working days after the user facility becomes aware of an event. The responsibility for reporting is limited to events involving patients and employees of the facility. Each device user facility is also required to submit to FDA, on a semiannual basis, a summary of reports it has submitted to both FDA and manufacturers. Section 519(d) of the act, as added by the SMDA, also requires manufacturers to certify to FDA the number of reports submitted in the preceding 12-month period or, alternatively, certify that no such reports have been submitted to the agency during the same period. FDA believes that section 519 of the act, as amended by the SMDA and the 1992 amendments, provides clear authority to issue this regulation for manufacturers and user facility reporting. Moreover, FDA does not believe that the provisions of this regulation are overly broad or unduly burdensome. FDA has reviewed and revised the regulation to clarify and limit the scope as appropriate. FDA believes that certain classes of persons, which might otherwise fit within the definition of manufacturer, should be exempt from the reporting requirements because reports from these persons are not necessary to ensure that the device is not adulterated or misbranded, and the device is otherwise safe and effective. Accordingly under Sec. 803.19, dental laboratories and optical laboratories have been exempted from the reporting requirements. FDA believes that these entities are not likely to receive reports of device-related deaths, serious injuries, or reportable malfunctions. In addition, requiring negative annual certification reports from these entities would be burdensome and not provide significant benefit to the public health. Therefore, FDA is excluding such entities from the reporting requirements. Other specific revisions are discussed in detail throughout this document. FDA believes this regulation carefully balances the interests of public health with industry burdens by limiting the required information to only that which is necessary to evaluate risks associated with medical devices and that it will enable the agency better to take appropriate regulatory measures to protect the public health. Furthermore, FDA does not believe that the burden on reporting entities will be significant. Based upon the number of reports FDA has received since the publication of the November 1991 tentative final rule, the agency anticipates that it will receive approximately 150,000 reports the first year of this reporting program (the agency currently receives over 100,000 reports annually). 2. Several comments pointed out that these provisions go beyond the scope of the SMDA in that the timeframes for reporting adverse events exceed the requirements of SMDA. Other comments argued that all employees of reporting entities should not be included under the reporting requirements of the SMDA, and that accordingly, the timeframes for reporting should not be triggered upon the knowledge of ``any employee'' of a reporting entity. FDA does not agree that the regulation's 10-day reporting timeframes for user facilities and 5-day and 30-day reporting timeframes for manufacturers are beyond the scope of the SMDA. Section 519(b)(1)(A) of the act specifies that user facilities must report certain adverse events as soon as practicable, but not later than 10 work days after becoming aware of the information. This section further specifies that FDA has the discretion to prescribe, by regulation, a shorter reporting period. While the statute does not specify the time periods allowed to manufacturers, the timeframes are consistent with section 519 of the act, the legislative history and FDA's public health responsibility to require that the reports are forwarded to the agency in a timely manner. FDA believes the time periods prescribed in the final regulation allow sufficient time for reporting entities to gather information, and are sufficiently time sensitive to allow the agency to respond rapidly and appropriately to protect the public health. FDA also does not agree that employees of reporting entities should not be subject to the reporting requirements and that timeframes for reporting should not be triggered when employees of the reporting entities become aware of events. The scope of the act does not exclude any responsible persons who are employees of these entities from complying with section 519 of the act. Under the final regulation, the reporting periods are based upon the time at which the reporting entity becomes aware of the reportable event. FDA believes that the final regulation's definition of ``becomes aware'' in Sec. 803.3(c) properly defines the types of user facility and manufacturer employees who must become aware of a reportable event in order to trigger the reporting requirement. FDA believes [[Page 63582]] that it will be feasible for user facilities and manufacturers to train the employees, described below, to be familiar enough with the obligation to report adverse events immediately to the appropriate person that the manufacturer or user facility designates as responsible for MDR reporting. Under Sec. 803.3(c), a device user facility is deemed to have ``become aware'' when medical personnel of a facility become aware of a reportable event. ``Medical personnel'' are defined in Sec. 803.3(r) as individuals who are licensed, registered, or certified to administer health care; individuals with professional or scientific degrees; individuals who are responsible for receiving medical complaints or adverse event reports; or supervisors of such persons. FDA believes that a user facility can easily notify these types of employees about their obligation to immediately forward possible device-related adverse events to the appropriate person designated by the hospital to submit such reports. FDA believes that manufacturers have a direct responsibility to inform all employees to immediately forward adverse event information to the appropriate person appointed by those entities to submit MDR reports. Accordingly, FDA generally considers that a manufacturer becomes aware of an adverse event whenever any employee becomes aware of an adverse event. The one exception is for 5-day reports under Sec. 803.53(b), which requires manufacturers to submit a report when the manufacturer becomes aware of information that an adverse event or events necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health. Under Sec. 803.53, manufacturers must submit a 5-day report under two different circumstances. The first type of 5-day reporting obligation arises after a manufacturer has received a written request from FDA for 5-day reports for specific types of adverse events. Under this circumstance, a 5-day report must be submitted when any employee becomes aware of an adverse event. FDA believes that the awareness of any employee should trigger the reporting requirement when FDA has informed the manufacturer of the need for specific adverse events that require 5-day reports because the manufacturer could easily inform all of its employees of FDA's request. The second type of 5-day report does not involve a direct request from FDA and is required only when the manufacturer becomes aware that an event or events necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health. Accordingly, this type of 5-day reporting requirement would only arise if remedial action were required, and the remedial action is necessary to prevent an unreasonable risk of substantial harm to the public health. If no remedial action is required, or the remedial action is taken but it is not necessary to prevent an unreasonable risk to the public health, reportable adverse events should be submitted as 30 day reports. Because FDA does not believe certain employees, such as non- technical staff, would be able to recognize that an adverse event or events may require remedial action to prevent a substantial risk to the public health, the final regulation requires that these types of 5-day reports be submitted only when employees holding certain positions of responsibility become aware of adverse event information. Accordingly, the final regulation considers a manufacturer to be aware of this type of 5-day report only when an employee with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or a person whose duties relate to the collection and reporting of adverse events, becomes aware that a reportable MDR event or events necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health. FDA believes that limiting the type of person who must be aware of the adverse event to these types of individuals is appropriate because persons in these positions should be able to recognize that the event or events may present significant risks to the public health. 3. Some comments suggested limiting the scope of these provisions so that reporting is required only when there is a death or serious injury. Other comments suggested that reports not be required if the device was only indirectly responsible for a death or serious injury, or was not a significant factor. Another comment suggested that reporting be limited to instances of malfunction. Section 519 of the act provides FDA with authority to require reporting of adverse events other than deaths or serious injuries. FDA has exercised this authority since 1984 by requiring manufacturers to report certain malfunctions. Moreover, section 519(a)(1) of the act (as amended by section 5 of the 1992 amendments) specifically states FDA's adverse event reporting regulations must require manufacturers to report malfunctions if the recurrence of the malfunction would be likely to cause a death or serious injury, regardless of whether an actual death or injury occurs. Because devices with such malfunctions pose significant risks, FDA needs to be informed of these incidents. The final regulation, therefore, requires manufacturers to report malfunctions when recurrence would be likely to cause a death or serious injury. User facilities are encouraged but not required to report malfunctions to manufacturers and distributors. Section 519(b)(1)(B)(ii) of the act, as added by the 1992 amendments, also provides FDA with authority to require user facilities, distributors, and manufacturers to report other significant adverse device experiences that FDA determines necessary. Therefore, in a future issue of the Federal Register, FDA will propose to require that certain events be reported as significant adverse device experiences. Although some of these experiences may not have caused harm, FDA believes such events should be reported because of the potential risk to the public health if the event were to recur. Such information will enable the agency to take appropriate measures to prevent such recurrences. FDA also disagrees with the comments stating that reporting should be required only when a device directly causes an adverse event or is a significant factor. Section 519(a)(1) and (b)(1)(A) of the act requires reporting of any adverse event when information reasonably suggests that a marketed device ``may have caused or contributed'' to a reportable event (emphasis added). Limiting reporting to adverse events directly or significantly caused by devices would narrow the statutory reporting standard which requires reporting of adverse events when a device ``may have caused or contributed'' to an adverse event (emphasis added). FDA cannot agree with the comment that suggested reporting be limited to instances of malfunction. As stated above, section 519 of the act requires reporting of deaths and serious injuries, and authorizes FDA to require reporting of other significant adverse device experiences, as well as malfunctions. FDA does not agree with the comments that reporting should not be required when events are anticipated or intrinsically caused by the device. The statute does not exempt events that were anticipated or intrinsically caused by the device. (See section 519(a) (1) and (b)(1)(B) of the act.) Moreover, merely knowing that adverse events are anticipated or intrinsically caused by a device does not obviate the need for information contained in event reports. [[Page 63583]] FDA needs to know the frequency and severity of adverse events in order to take appropriate action. 4. One comment objected to providing warranty information. Other comments stated that a manufacturer's responsibility to report should end at the expiration of the warranty. The agency disagrees. Reporting requirements under section 519 of the act are not restricted or limited in any way by manufacturer warranties. Section 519 of the act requires manufacturers to report certain adverse events regardless of whether the warranty has expired. Warranties are private contracts between the purchaser and the manufacturer. In order to protect the public health and determine whether actions should be taken with respect to a device associated with an adverse event, FDA must receive information regarding all reportable events, including those that occur after a manufacturer's warranty has expired. 5. One comment stated that certain adverse events may result from the user not knowing how to properly use the device, and that this would lead to the reporting of events properly attributable not to the device, but to its incorrect use. As with the 1984 manufacturer adverse event reporting regulation, this rule requires reports of certain adverse device events caused by user error. Device injuries attributed to user error may indicate that the device is misbranded within the meaning of section 502(f) of the act (21 U.S.C. 352(f)) in that the device fails to bear adequate directions for use or adequate warnings. In such cases, reports of adverse events that result from user error may alert FDA to the need for improved labeling to prevent future injuries. 6. One comment suggested that independent device service personnel be added to the list of people required to report because some manufacturers may not receive reports from their own service personnel. Under section 519 of the act, only user facilities, manufacturers, and distributors are required to report adverse events to FDA. User facilities are considered to have ``become aware'' of such information whenever any medical personnel becomes aware of a reportable event. Manufacturers are considered to have ``become aware'' of events required to be reported in 30 days, or required to be reported in 5 days, pursuant to an FDA request, when any employee becomes aware of an adverse event. Manufacturers are considered to have become aware of significant risk 5-day reports, which are more fully described in IV.A., comment 2, of this document, only when certain higher level employees become aware of adverse events requiring remedial action. FDA believes that an employee of a manufacturer includes independent service personnel who are contracted by manufacturers to service their medical devices. It is the responsibility of manufacturers to ensure that their service personnel, whether staff employees or under contract, are informed of the requirement to report deaths, serious injuries, malfunctions, or other significant adverse device experiences that may be required by regulation in the future. B. Section 803.3--Definitions 7. Many comments stated that the definition of ``device family'' (Sec. 803.3(e)) that is used to identify similar groups of devices on the manufacturer baseline report, is vague and overly broad. One comment suggested that each device be listed in the regulation; others suggested that the definition be deleted. FDA does not agree that the definition should be deleted. The identification of the device family on the baseline reports for individual device models will help FDA and manufacturers group similar models for analysis. This will aid in identifying the causation and nature of device-related problems. FDA agrees, however, that the definition should be clarified and has revised it accordingly. Manufacturers may use their own methods of grouping devices if the groupings meet the definition of ``device family,'' i.e., the devices have the same basic design and performance characteristics related to safety and effectiveness, intended use and function, and device classification and product code. FDA has the discretion to determine the appropriateness of a manufacturer's determination of the devices that comprise a device family. It would be impractical to list each device in the regulation. 8. Many comments stated that the definition of ``device user facility'' (Sec. 803.3(f)) is vague. Several of these comments requested clarification regarding what facilities are included in the definition. Several comments suggested that certain groups (i.e., blood banks, independent rescue squads, school clinics or nurse offices, employee health units, dental offices and free-standing care units operating as private physician offices) be specifically included or excluded from the definition. FDA agrees in part. Under section 519(b)(5)(A) of the act, FDA has exercised its discretion to include outpatient diagnostic facilities that are not physician offices in the definition of ``device user facility.'' Under Sec. 803.3(f), device user facility means ``a hospital, ambulatory surgical facility, nursing home, or an outpatient diagnostic or treatment facility which is not a physician's office.'' To further clarify this definition, FDA has included definitions for the terms ``physician's office'' (Sec. 803.3(w)), ``hospital'' (Sec. 803.3(l)), ``ambulatory surgical facility,'' (Sec. 803.3(b)), ``nursing home'' (Sec. 803.3(s)), ``outpatient diagnostic facility'' (Sec. 803.3(t)), and ``outpatient treatment facility'' (Sec. 803.3(u)). Under section 519(b)(5)(A) of the act, physicians' offices are excluded from the definition of user facilities and are thereby excluded from adverse event reporting requirements. FDA believes that groups performing functions similar to physicians' offices such as dental offices and offices of other health care practitioners (e.g., chiropractors, optometrists, nurse practitioners, school nurse offices, employee health clinics, free-standing care units) fall within the definition of ``physician's office'' and therefore should be excluded from reporting. FDA invites further public comment on the definition of ``physician's office'' and may issue further guidance as necessary. FDA has defined ``outpatient treatment facility'' as a distinct entity that operates for the primary purpose of providing non-surgical therapeutic care. FDA believes that ambulance or rescue squad services and independent home health care agencies fall within this definition. Given the critical risks posed by potential malfunctions of devices used by ambulance services and in home health care settings, FDA believes the inclusion of these services within the definition of ``outpatient treatment facility'' is appropriate. Blood banks that operate in hospitals or as outpatient treatment or outpatient diagnostic centers fall within the definition of user facility. Accordingly, device-related adverse events that meet the definition of MDR reportable event, as defined in Sec. 803.3(q), that occur in such blood banks must be reported. FDA invites further public comment on the definition of user facility and may issue further guidance as necessary. 9. Several comments stated that the definition of ``imminent hazard'' relating to types of adverse events that FDA proposed should have 3-day reporting timeframes (proposed Sec. 803.3(g)) is unclear. A few comments suggested that the definition be deleted because it is too subjective, belongs in another regulation, or is beyond the scope of the SMDA. Some comments [[Page 63584]] stated that more than 3 days were needed for reporting. FDA agrees. The agency is extending the time period to make such reports from 3 days to 5 days. FDA is also renaming ``imminent hazard reports'' as ``5-day reports'' (defined in Sec. 803.3(k)), and has clarified this requirement in Sec. 803.53. The purpose of the 5-day report is to alert the agency rapidly to adverse events that may pose an unreasonable risk of substantial harm to the public health. Thus, the definition of ``5-day report'' has been revised to mean a report of an adverse event required by a manufacturer, submitted on FDA Form 3500A or an FDA approved electronic equivalent within 5 work days of: (1) Any employee, who is a person with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or a person whose duties relate to the collection and reporting of adverse events, becoming aware that a reportable MDR event or events, from any information, including any trend analysis, necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health; or (2) any employee becoming aware of an adverse event, if the manufacturer has received a written request from FDA for the submission of a 5-day report for those types of adverse events. When such a request is made, the manufacturer shall submit a 5-day report for all subsequent adverse events of the same nature that involve substantially similar devices for the time period specified in the written request. The time period stated in the original written request can be extended by FDA if it is in the interest of the public health. FDA does not intend that a manufacturer delay or interrupt a remedial action in order to submit a 5-day report. The report must be made within 5 days of the manufacturer becoming aware that a reportable event or events necessitate remedial action to prevent unreasonable risk of substantial harm to the public health. Information that would reasonably suggest remedial action is necessary to prevent such risk may, for example, be from one MDR reportable event that makes the manufacturer aware of a serious design flaw that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public. On the other hand, information that would reasonably suggest remedial action is necessary may result from an internal trending analysis of several MDR reports that make the manufacturer aware that serious injuries or deaths occur at a much higher frequency than expected. Further discussion relating to when a manufacturer is considered aware of a reportable event is in section IV.A., comment 2, of this document. Manufacturers who submit 5-day reports are not required to submit reports of removals and corrections under section 519(f) of the act. Any information not available for reporting under the 5-day reporting timeframe may be submitted in a supplemental report. FDA does not agree with comments asserting that 5-day reports are beyond the scope of the SMDA or belong in another regulation. Requiring 5-day reports is consistent with FDA's authority under section 519(a)(1) of the act to issue regulations requiring manufacturers to report information that reasonably suggests that one of their marketed devices ``may have caused or contributed to a death or serious injury, or has malfunctioned and that such device * * * would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.'' For the protection of the public health, FDA may limit the time allowed to manufacturers for reporting events of which the agency should be quickly aware. 10. Many comments stated that the requirements relating to user facility incident files (proposed Sec. 803.35(c)) that contain documents related to adverse events that a user facility must maintain are overly burdensome because the definition of ``incident files'' in proposed Sec. 803.3(h) is overly broad. Many of these comments suggested that the definition of incident files be removed or changed in order to clarify or limit the scope of requirements relating to the files. Other comments suggested that FDA's access to the files be limited. The agency agrees that the definition of these files (which have been renamed ``MDR event files'' in Sec. 803.18 of the final regulation) could be narrowed. Accordingly, FDA has revised the definition of MDR event files to include MDR reports filed with FDA or other entities, and documents related to the adverse event, including documents relating to deliberations and decisionmaking processes used in the evaluation or determination of whether an event is an MDR reportable event. The final rule also allows the reporter to incorporate certain information by reference, such as medical records, patient files, and engineering reports, rather than include them in the MDR event file. FDA does not agree that agency access to user facility files should be limited. Under Sec. 803.18(b), user facilities shall permit any authorized FDA employee during all reasonable times to have access to, and to copy and verify the records required under part 803. FDA has authority to inspect files under section 704(e) of the act (21 U.S.C. 374(e)). Section 704(e) of the act states that every person required to maintain records under section 519 of the act, and every person who is in charge or custody of such records, shall permit FDA at all reasonable times to have access to and to copy and verify such records. In issuing a regulation stating its authority under section 704(e) of the act to have access to user facility adverse event files, FDA is exercising its duty under the statute to protect the public health by ensuring that user facilities comply with reporting requirements issued under section 519 of the act. 11. Several comments stated that the definition of what kind of information triggers the reporting requirements, specifically, the definition of ``information that reasonably suggests that there is a probability that a device has caused or contributed to a death or serious injury, or serious illness'' (proposed Sec. 803.3(i)), is unclear and requires further definition. The agency agrees and has clarified this concept in Sec. 803.20(c). As explained in section II.B.1 of this document, section 5 of the 1992 amendments revised section 519(a)(1) of the act, subsequent to FDA's November 1991 tentative final rule, to require the agency to issue regulations that require manufacturers and importers to report to FDA ``whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices: (1) May have caused or contributed to a death or serious injury, or (2) has malfunctioned and that such device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.'' Similarly, section 5 of the 1992 amendments revised the reporting standard for user facilities under section 519(b)(1) (A) and (B) of the act to require a user facility to submit a report whenever it receives or otherwise becomes aware of information ``that reasonably suggests that a device has or may have caused or contributed to a death * * * or serious illness of, or serious injury to, a patient of the facility * * *.'' Under the revised 1992 amendments' statutory reporting standards, FDA has no discretion to change the reporting standards for manufacturers and user [[Page 63585]] facilities. Accordingly, FDA has revised the wording of the reporting standards in the final regulation for user facilities and manufacturers to reflect the exact wording in the 1992 amendments for these entities. Therefore, the final regulation requires user facilities and manufacturers to report certain adverse events whenever there is ``information that reasonably suggests that a device may have caused or contributed to a death or serious injury.'' The final rule describes, in Sec. 803.20(c) ``[i]nformation that reasonably suggests that a device has or may have caused or contributed to an MDR reportable event'' to be any information, such as professional, scientific or medical facts and observations or opinions, that would reasonably suggest that a device has caused or may have caused or contributed to an MDR reportable event. Reports are not required when there is information that would cause a person who is qualified to make a medical judgment (e.g., a physician, risk manager, or biomedical engineer) to reach a reasonable conclusion that a device did not cause or contribute to an MDR reportable event. Information that leads to the conclusion that an event is not reportable must be retained in the MDR event files for the time periods specified in Sec. 803.18. The final rule further defines, in Sec. 803.3(d), ``caused or contributed'' to mean that a death or serious injury was or may have been attributable to a medical device, or that a medical device was or may have been a factor in the adverse event including events occurring as the result of its failure, malfunction, improper or inadequate design, labeling, performance, manufacture, or user error. Devices may cause or contribute to MDR reportable events either directly or indirectly. 12. One comment stated that malfunctions of medical devices used for a nonmedical purpose should be exempted. Other comments stated that the term ``malfunction,'' as defined in Sec. 803.3(m), needed clarification, especially with regard to implanted devices. Another comment asked who is required to report implant malfunctions. Under this final regulation in subpart E of part 803 manufacturers must report certain malfunctions, including implant malfunctions, that would be likely to cause or contribute to an MDR reportable event, regardless of how the device is used. Although user facilities are not required by statute or regulation to report malfunctions, FDA encourages user facilities to report malfunction information to manufacturers and distributors. Malfunction reports provide important information to FDA concerning device safety. Reporters do not need to assess the likelihood that a malfunction will recur. The fact that the malfunction occurred once leads to the presumption that the malfunction will recur. A malfunction is reportable if any one of the following is true: (1) The chance of a death or serious injury occurring as a result of a recurrence of the malfunction is not remote; (2) the consequences of the malfunction affect the device in a catastrophic manner that may lead to a death or serious injury; (3) the malfunction results in the failure of the device to perform its essential function and compromises the device's therapeutic, monitoring or diagnostic effectiveness which could cause or contribute to a death or serious injury, or other significant adverse device experiences required by regulation (the essential function of a device refers, not only to the device's labeled use, but for any use widely prescribed within the practice of medicine); (4) the malfunction involves a long- term implant or a device that is considered to be life-supporting or life-sustaining and thus is essential to maintaining human life; or (5) the manufacturer takes or would be required to take an action under sections 518 or 519(f) of the act as a result of the malfunction of the device or other similar devices. Malfunctions are not reportable if they are not likely to result in a death, serious injury or other significant adverse device experience, that FDA, in a future rulemaking, may require by regulation. A malfunction which is or can be corrected during routine service or device maintenance must be reported if the recurrence of the malfunction would be likely to cause or contribute to a death or serious injury, or other significant adverse device experiences required by a future regulation. 13. Several comments stated that the definition of a ``manufacturer'' (Sec. 803.3(n)), who is subject to adverse event reporting requirements, is overly broad with regard to custom devices and devices modified by users. One comment suggested that the definition be modified to include manufacture for commercial distribution only. FDA believes that for protection of the public health, the definition should be broad enough to provide for reporting by all persons engaged in the manufacture, preparation, propagation, compounding, assembly or processing of medical devices, who may receive information about adverse events related to medical devices, except those manufacturers exempted under section 519(c) of the act and Sec. 803.19. Under section 519(c) of the act and Sec. 803.19, a practitioner licensed by law to prescribe or administer devices intended for use in humans and who manufactures or imports devices solely for use in the course of that individual's professional practice is exempt from reporting. Manufacturers of devices not being commercially distributed but which are being used under an investigational device exemption are required to report adverse events under parts 812 and 813 (21 CFR parts 812 and 813) and are not required to submit reports under part 803. Parts 812 and 813, however, require reporting of all adverse device effects. 14. Many comments stated that the definition of ``MDR reportable event'' (Sec. 803.3(q)) is unclear, beyond the scope of SMDA, or otherwise in need of revision. The definition of ``MDR reportable event'' has been modified to conform to revisions made to section 519 of the act by section 5 of the 1992 amendments. As defined in Sec. 803.3(q), the revised definition of ``MDR reportable event'' mirrors the language of section 519(a)(1) and (b)(1) of the act, as amended by section 5 of the 1992 amendments. FDA has further clarified terms contained in the definition of an ``MDR reportable event'' throughout this document. These include: ``caused or contributed,'' as defined in Sec. 803.3(d) and discussed in section IV.B., comment 11 of this document; ``information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury'' as defined in Sec. 803.20(c) and discussed in section IV. B., comment 11 of this document; ``malfunction'' as defined in Sec. 803.3(m) and discussed in section IV.B., comment 12 of this document; ``become aware'' as defined in Sec. 803.3(c) and discussed in sections IV.A., comments 2 and 6, and IV.D., comment 27 of this document; and ``serious injury,'' as defined in Sec. 803.3(aa) and discussed in section IV.B., comment 21 of this document. The terms ``necessitated medical or surgical intervention'' and ``permanent,'' which are now included in the definition of ``serious injury,'' are also clarified in this document. ``Necessitated medical or surgical intervention'' is discussed in section IV.B., comment 16 of this document. FDA believes that these added definitions and discussion of these terms this document provides adequate clarification of the term ``MDR reportable event.'' 15. A few comments stated that the definition of ``manufacturer report number'' (Sec. 803.3(o)), should be changed to allow flexibility and permit [[Page 63586]] manufacturers to use their own numbers. The agency disagrees. A uniform numbering system is essential for FDA evaluation of reports, recordkeeping, filing and analyses. Because the manufacturer report number is based on the manufacturer registration number and all manufacturing sites are required to have a registration number, there is no additional burden on the manufacturer to comply with this requirement. If the manufacturer reporting site does not have a registration number, FDA will assign a temporary registration until the site is officially registered. 16. Several comments stated that the definition of ``necessitated immediate medical or surgical intervention'' (proposed Sec. 803.3(o)), included as an element of the ``serious injury'' definition in Sec. 803.3(aa), which is unclear, overly broad, and unduly burdensome. Some of these comments suggested that the terms ``timely'' and ``intervention'' be further defined or a standard for ``immediate intervention be set (e.g., within 6 hours). Other comments suggested that the event be reported only if significant intervention actually occurred. In light of the 1992 amendments, most of the comments relating to the ``immediate medical or surgical intervention'' definition are no longer relevant. Section 5(a)(2) of the 1992 amendments revised and broadened the scope of reportable events that fall within the definition of ``serious injury'' by deleting the immediacy requirement from the definition. Under the 1992 amendments' revisions, FDA must require that injuries be reported that necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, that have or may have been caused by a device, regardless of the immediacy of the surgical or medical intervention. FDA agrees with comments suggesting that an event be reported if significant intervention actually occurred. FDA believes, however, that any intervention is per se ``significant'' if it is necessary to preclude permanent impairment of a body function or permanent damage to a body structure. 17. Many comments stated that the definition of ``patient of the facility'' whose serious injuries and deaths user facilities must report( Sec. 803.3(v)) is too broad. Several comments objected to including individuals being diagnosed, treated, or receiving care ``under the auspices of'' the facility under this definition. Other comments objected to including employees of the facility who suffer death or serious injury from a device used at or by the facility as a ``patient of the facility.'' They further asserted that FDA does not have clear jurisdiction over these types of employee events and that MDR reports would duplicate reports required by other regulations (e.g., Occupational Safety and Health Administration (OSHA) regulations). A few comments suggested that the term ``patient'' be further defined. The agency agrees that including any individuals treated or diagnosed ``under the auspices'' of a facility could be read very broadly to include certain individuals that are not intended to be covered by this regulation. Accordingly, FDA has revised this definition to include only individuals that are ``being diagnosed or treated and/or receiving medical care at or under the control or authority of the facility.'' FDA does not agree, however, that employees of the facility who are injured and/or receive medical care arising from a device-related event at the facility should be excluded from the definition of ``patient of the facility,'' and that information provided to other agencies for work-related injuries is duplicative of information required in an MDR report. FDA believes that facility employees who suffer injury or death in a device-related event reasonably fall within the meaning of the requirement under section 519(b)(1)(A) of the act to report such events that involve a ``patient of the facility.'' To ensure the safety and efficacy of devices, FDA needs information required in the MDR reports for all device-related adverse events regardless of the individual's employment relationship to the facility. MDR reports are required to provide information that is specifically tailored to help FDA determine the risks posed by a certain device and whether further action may be necessary. Reports required by other agencies relating to work injuries, such as OSHA, do not provide the MDR report information that is necessary for FDA to make these determinations. Accordingly, there is no unnecessary duplication involved in reporting. 18. A few comments stated that injuries must be reported because they are ``permanent,'' (proposed Sec. 803.3(q)), should exclude ``trivial'' or ``cosmetic'' irreversible damage. FDA agrees in part. To improve clarity, the agency has included the definition of ``permanent'' with the ``serious injury'' definition (Sec. 803.3(aa)). The agency has also modified the definition of ``serious injury'' to exclude trivial irreversible damage. While most cosmetic damage will be trivial, not all cosmetic damage would be considered trivial. Therefore, FDA is not excluding all cosmetic damage from this definition. 19. A few comments recommended that the definition of ``probability, probable, or probably'' in the reporting standard be clarified and suggested using a ``greater than 50 percent'' standard. As discussed earlier in this document, the 1992 amendments deleted the term ``probability'' from the reporting standard and revised the standard for manufacturers and user facilities. Therefore, this definition has been removed from the final rule. 20. A few comments stated that the definition of a ``remedial action,'' (Sec. 803.3(y)), which is required to be reported under Secs. 803.53(a) and 803.52(f)(7), is unclear. One comment suggested that the definition be deleted; another suggested that it be removed from the user reporting form. The agency does not agree that this definition should be deleted. The agency should be aware of remedial actions taken in response to reportable events in order to thoroughly evaluate the event. However, the definition has been reworded for clarity. Also, the request for remedial action information has been removed from the user facility section of the final reporting form (FDA Form 3500A) because user facilities do not ordinarily undertake remedial actions. The revised definition of ``remedial action'' appears in Sec. 803.3(y). 21. Several comments stated that the definition of a reportable ``serious injury or serious illness'' (Sec. 803.3(aa)) is overly broad and needs to be better defined. Another comment suggested that these terms be deleted from the manufacturer and distributor report forms altogether. One comment suggested that ``temporary damage'' be excluded from the definition. The agency disagrees with comments that requirements to report serious injuries or illnesses should be deleted from the manufacturer and distributor reporting form. Section 519(a)(1)(a) of the act requires manufacturers to report serious injuries. Nor does FDA agree that the definitions of these terms are overly broad. The regulatory definition in Sec. 803.3(aa) of the terms ``serious illness'' and ``serious injury'' are derived directly from the statutory definitions provided in section 519(a)(2) and (b)(5)(B) of the act, as amended by the 1992 amendments. The SMDA added section 519(b)(5)(B) to require that user facilities report ``serious illnesses'' as well as ``serious injuries.'' The 1992 amendments [[Page 63587]] amended section 519(a)(2) to require that manufacturers report only ``serious injuries.'' The statutory definitions of the terms ``serious injury'' and ``serious illness,'' however, are identical. (See section 519(a)(2) and (b)(5)(B) of the act.) The legislative history of the 1992 amendments indicates that ``the term 'injury' probably covers any illness that could be caused by a device * * *.''(138 Congressional Record H 3884 (1992).) In accordance with the statutory definition, FDA has defined ``serious injury'' to mean an injury or illness that is: (1) Life- threatening; (2) results in permanent impairment of a body function or permanent damage to body structure; or (3) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. As stated in response to comments described in section IV.B., comment 18 of this document, FDA has further clarified the definition of serious injury by clarifying the term ``permanent'' within the definition in Sec. 803.3(aa). Because section 519(a)(2) and (b)(5)(B), as amended by the 1992 amendments, identically defines the terms ``serious injury'' and ``serious illness'' FDA has revised the definition of the term ``serious injury'' to include ``serious illness.'' FDA does not agree with the comment stating that temporary damage should not fall within the definition of ``serious injury.'' Section 519(a)(2)(A) and (b)(5)(B) define serious injury to include any event that is ``life-threatening.'' Because life-threatening events may include temporary damage, FDA believes that life-threatening events that may have been caused by a device must be reported, regardless of whether the damage was ``temporary.'' 22. One comment stated that the definition of ``user facility report number'' (Sec. 803.3(dd)) needs to be more specific, especially regarding leading zeroes in the number. The agency agrees and has modified the definition for clarity. The revised definition appears in Sec. 803.3(dd). 23. Several comments requested that the terms: ``become aware,'' ``expected life,'' and ``shelf life'' be defined. FDA agrees. These definitions have been included in the final rule and appear in Sec. 803.3(c), (i), and (bb) respectively. For further discussion of the term ``become aware,'' see sections IV.A., comments 2, 6, and IV.D., comment 27 of this document. C. Section 803.9--Public Availability of Reports 24. Many comments expressed concern over confidentiality of the reports. The agency is aware of confidentiality concerns and will protect the confidentiality of information to the fullest extent allowed under the law. FDA is generally required, under the Freedom of Information Act (FOIA) (5 U.S.C. 552), to make publicly available reports received under this final rule. Public availability of such reports is governed by FOIA and part 20 (21 CFR part 20). Before a report is made publicly available, FDA, in accordance with FOIA and part 20 as promulgated in 1984, will delete from the report information whose disclosure would constitute an invasion of personal privacy (see 5 U.S.C. 552(b)(6); Sec. 20.63) or information that constitutes trade secret, confidential commercial or financial information (see 5 U.S.C. 552(b)(4); Sec. 20.61). Persons who are subjects of the reports, however, can receive all information in the report concerning themselves, except for trade secret, confidential commercial or financial information. FDA has modified Sec. 803.9 in this final rule to clarify that the identity of a third party who submits a voluntary adverse event report, such as a physician or other health care professional, will be protected. This revision does not add any new protection for voluntary third-party reporters. It merely clarifies that the existing protection afforded to voluntary reporters under Sec. 20.111 is applicable to MDR reports. Revised Sec. 803.9 incorporates the confidentiality provisions relating to user facility reporting in section 519(b)(2) of the act, as added by the SMDA. Specifically, Sec. 803.9(c) states that FDA may not disclose the identity of a device user facility except in connection with : (1) An action brought to enforce section 301(q) of the act (21 U.S.C. 331(q)), which includes the failure or refusal to furnish material or information required by section 519 of the act; (2) a communication to a manufacturer of a device which is the subject of a report of a death, serious injury or other significant adverse device experience required by a user facility under Sec. 803.30; (3) a disclosure relating to a manufacturer or distributor report which is required under section 519(a) of the act; and (4) a disclosure to employees of the Department of Health and Human Services, to the Department of Justice, or to duly authorized committees and subcommittees of the Congress. As stated above, Sec. 803.9, which is derived from the statutory language in section 519(b)(2)(C) of the act, allows disclosure of the user facility's identity when disclosure is required under provisions requiring manufacturer and distributor reporting. The legislative history of section 519(b)(2)(C) of the act states that this section is not intended to affect public access to information contained in MDR reports to FDA, and that the full requirements of reporting under section 519(a) of the act (the manufacturer and distributor reporting provisions), will apply. If a manufacturer chooses to forward a user report to FDA, that will then constitute a report described in section 519(a) of the act, not a report described in section 519(b) of the act, for purposes of public access to the contents of the report. (H. Rept. 101-808, 101st Cong., 2d sess., pp. 21-22). Accordingly, if information in a required user facility report is submitted as part of a distributor or manufacturer report, the information relating to the identity of the user facility would be disclosable because the report would be submitted under section 519(a) of the act. FDA notes that, in accordance with part 20 and section 519(b) of the act, the agency will not disclose the identity of the user facility physicians, persons designated by the user facility to submit reports, or other user facility employees, although the identity of the user facility may be disclosed. 25. Many comments expressed concern that the regulation will increase liability and that the availability of reports will lead to civil litigation. Although FDA is aware that litigants in civil suits may attempt to use information in adverse event reports as evidence in product liability suits, FDA does not have any information as to whether the information from reports will actually lead to the initiation or increase of civil litigation. Section 519 of the act requires user facilities and manufacturers to submit reports of adverse events. While these reports may have some effect on a reporter's liability, these regulations are required to implement statutory requirements. They are also necessary to make FDA aware of unsafe devices and better enable the agency to take appropriate action to safeguard the public health. With respect to user facilities, section 519(b)(3) of the act provides some protection against liability in that it prohibits the admissibility of device user facility adverse event reports into evidence for civil actions involving private parties, except where the party making the report had knowledge that information in the report is false. [[Page 63588]] With respect to manufacturers and distributors, FDA has attempted to provide protection from liability by clearly stating in Sec. 803.16 of this final rule, and including a statement on FDA Form 3500A, that the submission of a report does not constitute an admission that the user facility, manufacturer/distributor, product, or medical personnel caused or contributed to the event. Moreover, in the Federal Register of April 3, 1995 (60 FR 16962), FDA issued a final rule that became effective on July 3, 1995, that protects the identity of voluntary reporters by preempting State laws or other requirements requiring or permitting disclosure. 26. Comments objected to providing FDA with proprietary information. FDA may require the submission of certain proprietary information because it is necessary to fully evaluate the adverse event. Proprietary information will be kept confidential in accordance with Sec. 803.9, which prohibits public disclosure of trade secret or confidential commercial information, and in accordance with the FOIA and FDA regulations in 21 CFR part 20. D. Reports by Device User Facilities (Part 803, Subpart C) 27. Several comments stated that 10 days is too short a time period for user facilities to report adverse events properly. One comment suggested that the 10-day ``clock'' for reporting should commence when the facility completes its investigation and determines that an event is reportable. FDA cannot agree because the 10-day time period is the maximum time allowed by the statute. (See section 519(b)(1)(A) of the act.) However, this comment raises the issue of when the reporting ``clock'' starts. In the preamble to the November 1991 tentative final rule, FDA proposed to consider a user facility to have ``become aware'' of reportable events only when it has sufficient information to make a determination that a report is required, and that this commences the 10-day reporting period. (See the notice of availability of the MEDWATCH adverse event reporting form (FDA Form 3500A) in the Federal Register of June 3, 1993 (58 FR 31596.)) FDA has reevaluated the issue of when a user facility should be considered to ``become aware'' of information that triggers the reporting requirements and has determined that user facilities should be considered to have ``become aware'' of information that triggers reporting requirements when they first receive a report. The agency does not believe that information-gathering required of user facilities is sufficiently burdensome or time consuming to justify triggering the 10-day timeframe any time after they receive a report of an adverse event. A user facility, unlike a manufacturer, is not required to provide any information that is not in its possession. For further discussion on when user facilities are considered to have ``become aware'' of an event, see section IV.A, comment 2 of this document. 28. Several comments suggested that the user/operator error reporting requirement be eliminated. As stated in section IV.A., comment 3 of this document, the language of the SMDA as amended by the 1992 amendments requires reporting in all instances where the facility becomes aware of information that reasonably suggests that a device has or may have caused or contributed to certain device-related adverse events. FDA needs to be aware of events that are related to user error any time such error may have caused or contributed to a reportable event. By receiving information on device user problems, FDA can determine whether additional measures are necessary to resolve such problems, for example, relabeling or a redesign of the device. 29. One comment suggested that all reports be sent only to FDA. FDA does not agree. This regulation merely implements section 519(b) of the act, which requires user facilities to submit deaths to FDA and the manufacturer, and serious injuries to the manufacturer or FDA, if the identity of the manufacturer is unknown. 30. Some comments suggested that an anonymous reporting path be provided for reporting directly to FDA. FDA disagrees. It is important that both FDA and the manufacturer know the identity of the user facility in case followup information is needed. As discussed in section IV.C., comment 24 of this document, the act does provide some protection of the identity of user facilities. 31. Several comments requested clarification of the terms ``adverse events,'' ``formally affiliated,'' and ``user error.'' Adverse events are those events that may be related to an FDA- regulated product and which have a negative or harmful effect on the user or recipient of the product's use. The only adverse events required to be reported under this regulation, however, are ``MDR reportable events'' as defined in Sec. 803.3(q) of the final rule. The term ``formally affiliated'' means individuals who are employed by a user facility or medical personnel who have admitting, practicing, or equivalent privileges at a user facility. Reporting requirements for user facilities are triggered when medical personnel who are employed by or otherwise ``formally affiliated'' with the facility, receive information or become aware of information that reasonably suggests a reportable event has occurred. The term ``user error'' means any error made by the person using the device. A user error may be the sole cause or merely contribute to a reportable adverse event. 32. One comment suggested that FDA provide user facilities with manufacturer and agency contacts. Another comment suggested that a hotline be established for reporting. It would be very difficult for FDA to establish and maintain up-to- date manufacturer ``contact'' lists for device user facilities. The agency, however, will consider publicizing a list of firm contact names and telephone numbers. Although there is no requirement for telephone reporting in this regulation, emergency situations can be handled in accordance with Sec. 803.12(c) of this final rule. 33. One comment asked how foreign user facilities will be affected by these provisions. Only those user facilities located outside the United States which are operated by the U.S. Government are required to report under this regulation. 34. Comments suggested that the requirements for semiannual reports be deleted because they are redundant. Other comments suggested that no semiannual report be required if no reports had been submitted during that period. Semiannual reports are required by section 519(b)(1)(C) of the act and therefore the requirement cannot be deleted. Under Sec. 803.33(c), the user facility is not required to submit a semiannual report if no reportable events occurred during the reporting period. E. Reports by Manufacturers (Part 803, Subpart E) 35. One comment suggested that manufacturer reporting of ``planned remedial actions'' be deleted. Another comment stated that remedial action often occurs after the reporting deadline, and therefore cannot be included in the report. Remedial actions taken after a reporting deadline can be submitted to the agency via a supplemental report. The individual adverse event reports required under the final rule, with the exception of circumstances requiring 5-day reports, do not require information [[Page 63589]] concerning ``planned remedial action'' because supplemental reports and reports of Removals and Corrections will provide the agency with the same information. Remedial actions that are necessary to prevent an unreasonable risk to the public health should be reported as 5-day reports under to Sec. 803.53. 36. Several comments requested that manufacturers be exempt from the requirement of submitting supplemental reports because they are vague and burdensome. FDA does not agree. The supplemental report does not impose any significant additional burden under Sec. 803.56 because it requires information that a manufacturer was required to submit on its initial report, but did not do so because such information was unknown or unavailable at the time of the report. This information may include, for example, the results of a firm's investigations that may not have been completed at the time of the initial report, or any other required information that the manufacturer becomes aware of after filing a report. The information required is not vague and is clearly specified in Secs. 803.52 and 803.56. Both initial and supplemental reports are to be submitted on FDA Form 3500A or electronic equivalent. Under Sec. 803.15, FDA may also require supplemental information (termed ``request for additional information'' in the final rule) in addition to that required on other reports specified in this part. FDA believes these reports are not unduly burdensome given that they will be required only in instances when the agency determines that the protection of the public health requires such information. In such cases, FDA will specify the type of information needed. 37. One comment stated that the quality of information will decrease if manufacturers are denied access to products. FDA agrees that manufacturers should evaluate a device problem if they have access to the device. FDA has no authority to require that a device be returned to the manufacturer, but the agency encourages device users, when possible, to permit access or return the device to the manufacturer for evaluation. 38. One comment suggested that manufacturer reports should be sent to user facilities, as well as to FDA. FDA does not agree. FDA believes that user facilities do not have the appropriate resources or personnel to properly evaluate the public health significance of manufacturers' reports. FDA is the proper entity to evaluate MDR information to determine whether further action, including notification to user facilities or others of device risks, is appropriate. 39. A few comments suggested that the 1984 requirements for manufacturer reporting should be retained to avoid possible confusion caused by the creation of a new standard. Other comments called for the elimination of the monthly reporting requirement. As discussed earlier in the preamble, subsequent to the issuance of the November 1991 tentative final rule, the 1992 amendments modified the language for reporting standards that apply to user facilities, manufacturers, and importers. The language used in the November 1991 tentative final rule no longer reflected the statutory language, as modified. In this final regulation, FDA has revised the reporting standard to reflect the statutory language added by the 1992 amendments. This statutory reporting standard is substantially similar to the manufacturer reporting standard in the 1984 regulations. Although the final regulation retains the reporting standard language from the 1984 regulation referenced above, it incorporates many changes from that regulation that are intended to enhance the quality of the reports received and increase the efficiency of FDA's report processing. FDA believes the benefits of changes implemented by the new regulation far outweigh the limited costs for manufacturers to familiarize themselves with the new requirements. Under the final rule, manufacturers have 30 days after they become aware of an MDR event (with the exception of 5-day reports required by Sec. 803.53) to report the event to FDA. FDA, however, has eliminated the portions of monthly reporting requirements, as proposed, that would have required manufacturers to submit, in addition to individual adverse event report information, an evaluation of adverse events consisting of the results of a statistically-based trend analyses conducted by the manufacturer, a discussion of the underlying methodologies used, a description of any unusual or unexpected events, and a description of remedial action taken. As proposed, the greatest benefit of the evaluation portions of the monthly report would have been the overview of adverse experience trends it would provide. However, FDA has reevaluated the benefits of these monthly reports, and determined that the agency would incur the costs of data entry regardless of the industry's analysis, and that a computer program for the analysis of the data may be used at a relatively low cost to the agency. Furthermore, the agency anticipates that internal trending analysis will be conducted as part of a manufacturer's CGMP. Any remedial actions presenting an unreasonable risk of substantial harm that are undertaken based upon internal trend analyses are reportable in a 5-day report. Other essential information under the proposed monthly report will also be made available to the agency under the CGMP regulations, and would be made available to FDA under the proposed reports of removals and corrections regulation. The final regulation will also allow FDA to receive information about reports sooner than the monthly reports as previously proposed. The proposed regulation allowed the manufacturer up to 2 months from the date of an adverse event to submit the monthly report. For example, under the proposed regulation, information received by the manufacturer on January 1 would have been due in a monthly report in March. Under the final regulation, the manufacturer will submit all reports of adverse events within 30 days of the event. Accordingly, under the final rule, information about a reportable event the manufacturer received on January 1, would have to be reported within 30 days. FDA believes that the timeframes under the final regulation allow sufficient time for completing individual reports because the manufacturer would no longer be required to compile the trend analysis and other evaluations as previously proposed for the monthly reports. FDA also believes that the monthly reporting of individual adverse events in the final rule will achieve FDA's goal of obtaining better quality initial reports from manufacturers by allowing more time to complete the reports than allowed under the 1984 regulation. Nonetheless, the public health will benefit under the final rule because FDA will receive reports of individual events sooner than under the proposed rule. 40. One comment objected to the use of identification (ID) numbers on the reporting form, claiming they are unnecessary. The agency disagrees. Report ID numbers are essential to FDA's ability to efficiently audit, process, analyze and evaluate MDR data. One of the major deficiencies of the current system is its inability to consistently identify similar devices and other data elements that facilitate the comparison of adverse events. The use of device ID numbers (Secs. 803.32(c)(6) and 803.52(c)(6)), user facility and manufacturer report numbers (Secs. 803.3(dd) and (o), respectively)), and event codes [[Page 63590]] (discussed in section IV.F., comment 52 of this document) will facilitate information access and retrieval, and increase the agency's ability to evaluate the information. 41. Comments stated that the requirement for firms to compare events associated with the use of their devices, in order to perform trending studies, should be removed. The agency agrees in part and has deleted MDR trending reporting requirements, as discussed in section IV.E, comment 39 of this document. Under the prior reporting regulation, FDA has faced difficulties in making an effective determination of the significance of many device failures, because the reports did not include the total number of similar devices in current use or similar failures. Such information, which is required in baseline reports, provides the agency with information regarding the rate of adverse events. An understanding of device failure rates is essential for the agency to determine the level of risk involved, and the appropriate regulatory or other public health response. 42. One comment suggested that instead of the manufacturer indicating to whom the information was reported in the monthly reporting form, it is more important to indicate by whom it was reported. The agency agrees in part. As noted above, the monthly report requirement, as proposed, has been eliminated; however, information about the initial reporter is required on the individual adverse event MEDWATCH form (FDA Form 3500A or an FDA approved electronic equivalent). 43. One comment objected to the requirement to report problems found in the scientific literature. Another comment objected to reporting anything except problems found in the scientific literature or from research. Any information which reasonably suggests that a reportable event occurred is important to evaluate the risks of a device, regardless of the source. Although reports in the scientific literature or research are usually not proximate in time to actual events, the information often represents the results of cumulative observations and experience, and provides important information to FDA about device safety and effectiveness. 44. One comment stated that the manufacturer reporting requirements are inappropriate for device sales made directly to the patient. The agency disagrees. The act does not provide any restrictions or limitations with respect to how the device was marketed. FDA would lose a valuable source of information if manufacturers of devices sold directly to patients, such as many apnea monitors or home use glucose monitors, were excluded from this requirement. All information concerning device-related deaths, serious injuries or other reportable events is equally important, regardless of how the device is marketed. 45. One comment stated that there is no relationship between devices shipped by the manufacturer and those on the market, as the devices may have been altered; therefore, the manufacturer should not be responsible for reporting events involving such devices. The agency disagrees. Devices in commercial distribution are presumed to be the same devices shipped by the manufacturer. If a manufacturer receives information about an MDR event involving a device that has been altered, the information must nevertheless be forwarded to FDA with an explanation that the device has been altered. 46. One comment suggested that a U.S.-designated agent should be responsible for reporting on behalf of foreign manufacturers. FDA's November 1991 tentative final rule proposed that U.S.- designated agents should be required to report for foreign manufacturers. This requirement has been adopted in Sec. 803.58. 47. One comment suggested that the manufacturer should disclose the results of event evaluations to distributors of the device. FDA does not agree. Disclosure of evaluations would be burdensome and may result in release of information that is protected under other laws and regulations. FDA will inform the public, including distributors, of steps necessary to protect the public health if the agency determines such steps are necessary. F. User Facility and Manufacturer Reporting Forms for Individual Adverse Events (Secs. 803.32 and 803.52) 48. Several comments asserted that this section is costly, complicated, overly broad, unacceptably burdensome and not consistent with the SMDA as it requires the reporting of information not required or supported by the SMDA. The agency disagrees. As stated earlier in the preamble, FDA has adopted the use of a single reporting form for most FDA-regulated products, in order to facilitate the cost-efficient submission of information required by or consistent with the provisions of the SMDA. The agency agrees that the data elements could be simplified and has modified the form after consideration of comments to the February 1993 notice submitted by medical device trade associations and other regulated or affected entities. FDA anticipates that the consolidated form will facilitate the submission, and improve the quality, of adverse event reports. During the initial period of its use, FDA will continue to closely monitor comments and suggestions received from interested parties regarding the reporting form, and will consider additional modifications to further improve the form as the need arises. 49. One comment stated that it will be difficult to find manufacturer reporting forms. Another comment stated that the report form, distributed as a draft to certain interested parties, is not compatible with the use of a word processor. The MEDWATCH forms (FDA Forms 3500 and 3500A) are already in wide distribution and were published in the Federal Register on June 3, 1993. Information about the MEDWATCH form, and how to obtain it, is provided Secs. 803.10 and 803.11. Although a word processor would be able to fill the fields on FDA Form 3500A with great difficulty, the agency has made provisions for the submission of reports on alternative (electronic) media which would obviate the need for printing the form from a word processor. 50. Several comments were concerned with the adversarial and litigation issues which may be raised by reporting on the forms. In this regard, a few comments suggested deleting all items that require speculation and judgment in reporting, removing the signature block, or adding a disclaimer to the form. As stated in section IV.C., comment 25 of this document, although FDA is aware that these reports may have some effect on liability, the required information is necessary to implement the agency's statutory responsibilities. Under the statute, user facilities and manufacturers must report adverse events when a device ``may'' have caused or contributed to the event. Accordingly, FDA does not have the discretion to require reporting only when a definitive causal relationship is established. Furthermore, adoption of such a standard would preclude FDA from receiving information that would help the agency assess the risks associated with devices. FDA has removed the signature block on the form. FDA has provided a disclaimer statement on the reporting form, as discussed in section IV.C., comment 25 of this document. 51. Some comments suggested that the evaluation of events or reports be [[Page 63591]] left to FDA, the manufacturer or another third party. Other comments suggested that the manufacturer should not be required to verify data or provide data about which it has no knowledge. Other comments suggested that user facilities do not have the appropriate expertise to analyze events or make determinations concerning the reportability of events. FDA agrees that user facilities should not be required to conduct in-depth analyses of events and has deleted certain requirements regarding information relating to evaluation and testing. User facilities serve principally as conduits of information and thus are required only to fill out information that is known to them. However, the statute and regulations still require user facilities to make an initial determination as to whether an event should be reported under the regulation's criteria. Accordingly, FDA has retained elements that relate to this determination. In Sec. 803.30, FDA explains user facilities' obligations to obtain information about adverse events. FDA believes that the manufacturer who is responsible for placing a device into interstate commerce is the appropriate entity to initially investigate and evaluate whether, and why, the device may have caused or contributed to a reportable event or malfunctioned and that such malfunction is a reportable event. In order for FDA to determine whether the risk posed by a device necessitates action to protect the public health, the manufacturer is also required to verify data and provide missing information after investigating the event. If after an investigation the information cannot be determined, a manufacturer must explain in the MDR report why the information cannot be obtained. The agency agrees that an analysis of reports for patterns and trends may be more appropriately conducted by the manufacturer or FDA. FDA will conduct statistical analyses of report information submitted. The agency expects that manufacturers will conduct trend analyses as part of their CGMP. 52. Several comments suggested that numerical event and evaluation codes should not be used on the adverse event reporting form. Other comments stated that the codes lacked accuracy or were insufficient. The agency disagrees. It is the manufacturer's responsibility to evaluate reports to determine causation. It is reasonable that an evaluation will result in the assignment or identification of failure modes and that these can be communicated to FDA in the form of a structured vocabulary or ``coded'' data. In developing these codes, the agency has used the experience gained from reviewing nearly 400,000 reports submitted since 1984. The use of these codes is essential to the rapid evaluation of device risks and processing of reports by computer. Regardless of whether the codes are specific enough to describe a particular event, the event must be fully described in the narrative section of the reporting form. The list of codes for use with the final form (FDA Form 3500A or FDA approved electronic equivalent) has been expanded for completeness and modified to improve accuracy. The agency will continue to improve the accuracy of its codes as needed. 53. Various comments suggested that the following elements be removed from the form: Degree of certainty, labelled usage, result of analysis, list of other devices, purchase date, service and maintenance items, event description, and medical status of the patient. FDA has deleted requirements for user facilities and manufacturers to report service and maintenance information and to state the degree of certainty concerning whether the device caused or contributed to an adverse event. FDA believes the burden of requiring this information would usually outweigh the benefit of assessing the cause of an adverse event. FDA, however, has retained the requirements for manufacturers to report use indications specified in the labeling and device analyses because this information is valuable in determining causation of the event. FDA has deleted the requirements to report these elements for user facilities because the agency believes the manufacturer is the most appropriate source for this information. All user facilities and manufacturers will still be required to provide information regarding concomitant product use, age of the device, event description and certain patient information. FDA believes this information is important to assess adverse events and should be available to user facilities as well as manufacturers. G. Manufacturer Annual Certification Report (Sec. 803.57) 54. A few comments stated that this section is redundant, overly broad and burdensome, exceeds the scope of the SMDA and should be deleted. Another comment suggested that certification be limited to events involving class III devices. The agency cannot agree. Section 519(d) of the act states that each manufacturer required to make reports under section 519(a) of the act must submit annual statements certifying the number of reports filed or that no reports were filed during the previous 12-month period. The provisions of this regulation pertaining to the statutory certification requirement merely explain what information should be contained in the submission. Furthermore, FDA does not agree that certification should be limited to reports about adverse events involving class III devices. Any device, regardless of its classification, can pose serious risks that need to be reported to FDA. 55. Some comments suggested that the certification be limited to the number of reports actually filed, and that liability should attach only in instances of known reporting violations. The agency disagrees. The purpose of this provision is to ensure reporter compliance with MDR requirements by certifying that all reportable events have been submitted. Such purpose would be thwarted and the certification requirement rendered meaningless if it were limited to simply certifying the number of reports submitted instead of all reportable events known to the certifying entity. The legislative history of section 519(d) of the act references a U.S. General Accounting Office recommendation that the certification state that the reporter ``filed a specific number of reports * * * and that the firm received or became aware of information concerning only these events.'' (H. Rept. 808, 101st Cong., 2d sess. 23 (1990)). Accordingly, consistent with Congress' intent, FDA is requiring certification that all known reportable events were reported. This requirement does not impose liability for adverse events that are unknown to the reporter because the reporting requirements are triggered only when the reporting entity ``becomes aware'' of a reportable event. 56. Several comments stated that the purpose of certification should be to verify reports, not to certify with absoluteness; therefore the standard should be changed to ``reasonably certain'' and a disclaimer should be added. The agency disagrees. Section 519(d) of the act specifically states that firms shall certify, not verify their reports. As discussed in the previous paragraph, the purpose of this provision is to ensure that the reporter complies with the law by certifying that it has submitted all the reports it was required to submit. This purpose would not be accomplished by verifying the report. 57. One comment asked for clarification about who is required to certify. Another comment suggested that [[Page 63592]] the signature block be for the certifier and contractor as well. The agency agrees with the need for clarification regarding who must certify and has incorporated language in the final rule to address this suggestion. Under the final rule, the president, chief executive officer, executive officer, U.S.-designated agent of a foreign manufacturer or other official most directly responsible for the firm's operations shall certify reports submitted under section 519 of the act. 58. Two comments requested that decentralized certification be allowed for multisite firms. Another comment suggested that centralized reports be used in this situation. Manufacturers have the option of certifying centrally or on a decentralized basis. Firms deciding to certify centrally must identify the sites covered by the certificate by name and registration number or FDA-assigned identification number. H. Additional Requirements (Sec. 803.15) 59. A few comments asserted that these provisions are vague and inappropriate in the absence of a device failure complaint. The agency disagrees. This provision refers to submission of additional information after an adverse event report has been filed. Accordingly, FDA would not be requesting information in the absence of a device failure or complaint. 60. A few comments objected to the idea of giving FDA unlimited access to data. One comment wanted to restrict FDA's right to copy data and another wanted an appeal process. FDA does not agree with comments proposing to restrict or limit the agency's access to additional information about adverse events. Under section 704(e) of the act, every person who is required to maintain records under section 519 of the act and every person who is in charge or custody of such records must permit FDA at all reasonable times to have access to and to copy and verify such records. Failure to provide such information may be a violation of section 301 of the act and may subject a person to civil or criminal penalties. Section 704(e) of the act does not limit in any way the types of device records maintained under section 519 of the act that FDA may inspect. FDA does not agree that the agency should be required to provide an appeal process with respect to requests for additional information. As described above, FDA has statutory authority to require additional information concerning adverse events. Moreover, such information needs to be provided as quickly as possible to enable FDA to take appropriate action. 61. Several comments suggested the regulation be modified to remove the requirement that each reportable event be investigated because in some instances an investigation is unnecessary. The agency disagrees. All reportable events must be investigated by the manufacturer. The scope of an investigation may vary according to the circumstances; however, an investigation must be able to adequately assess the cause of the event. Sections 820.162 and 820.198 of FDA's CGMP regulations require manufacturers to review, evaluate and investigate any complaint involving the failure of a device to meet its performance specifications or involving injury, death, or any hazard to safety. FDA considers any event that must be reported under this part to be a death, injury, or hazard to safety. I. Exemptions, Variances, and Alternative Reporting Requirements (Sec. 803.19) 62. One comment asked that alternative reporting requirements under the current MDR system be incorporated into this regulation. One comment stated that the criteria for alternative reporting should be clarified. FDA has incorporated the alternative reporting options from the MDR regulation issued in 1984 and expanded the options available in this regulation. Under the final regulation, FDA may grant a written exemption, variance, or alternative to some or all of the requirements when it determines compliance with all MDR requirements is not necessary to protect the public health. Examples of situations include: (1) Devices for which FDA is already aware of a type of malfunction and appropriate action has been taken to protect the public health, such as a recall, removal, or other correction; (2) adverse events that are known and well documented, are occurring at a normal rate, and do not justify the initiation of remedial action; and (3) device events occurring on an infrequent basis or where a longer period for investigation or followup is appropriate and necessary. In these cases, FDA may impose conditions on its approval of an exemption, variance, or alternative reporting mechanism, including the requirement to report on a less frequent basis than otherwise required or to provide summary data rather than individual reports. The final regulation, upon its effective date, will supersede all previously granted exemptions and variances from the 1984 reporting requirements. The agency intends to review all current exemptions and variances and notify relevant parties about the status of their exemptions and variances and the additional steps that may be necessary to conform to the new requirements effected by this regulation. 63. A few comments stated the criteria for exemption are unclear, especially with respect to investigational device exemptions, and thus create a loophole. The criteria for exemptions (Sec. 803.19) are based upon interpretations of the act as to the types of entities Congress intended should be subject to reporting. FDA believes these exemptions are reasonably clear. The exemptions specifically granted under this final regulation are the same as those in the MDR regulation issued in 1984. Devices subject to investigational device exemptions are subject to reporting under the regulations governing that process (parts 812 and 813). The exception to this are devices with investigational device exemptions that are approved for export. These devices are considered to be in commercial distribution and, therefore, subject to MDR. J. Where To Submit a Report (Sec. 803.12) 64. There were only two comments on this section. One suggested that ``MDR'' be added to the mailing address. The other recommended the use of electronic reporting. The agency agrees with these comments. ``MDR'' has been added to the mailing address. In addition, the agency, with prior approval, will accept required reports submitted electronically or on reporting media such as magnetic disc or tape in accordance with Sec. 803.14(a). The agency is in the process of developing standards, guidelines, or procedures for the format to be used with electronic reports. Once available, any electronic reporting system meeting such criteria will be deemed to have prior FDA approval. K. Written MDR Procedures (Sec. 803.17) 65. A few comments requested additional guidance on written MDR procedures. FDA agrees and has developed guidance concerning MDR procedures. Requests for this guidance should be directed to: Division of Small Manufacturers Assistance (HFZ-220), Office of Health and Industry Programs, Center for Devices and Radiological Health, 1350 Piccard Dr., Rockville, MD 20850. [[Page 63593]] Copies can also be obtained from an electronic docket maintained by the Division of Small Manufacturers Assistance. This system can also be accessed by dialing: 1-800-252-1366 or 301-594-2741. Persons wishing to obtain the guidance document via this system must have a video terminal or a personal computer with communication software (VT emulation) and a modem that can operate at a baud rate of 1200, 2400, 4800, or 9600. Persons wishing to transfer files from the electronic docket must use the KERMIT file transfer protocol. 66. One comment requested that the requirement for staff education be deleted. The agency agrees and, as stated previously in this preamble, has removed this requirement from the final regulation. 67. One comment objected to the requirement for written procedures. Another comment objected to FDA having access to the firm's procedures. The agency disagrees. Written procedures are essential to the development of a standard, institutional reporting program. FDA also needs access to such procedures so it can conduct an adequate audit of user facility and manufacturer compliance with MDR. 68. One comment requested clarification of the term ``information that facilitates a submission'' for which documentation and recordkeeping requirements were proposed. ``Information that facilitates the submission [of a semiannual report]'' refers to any information that was evaluated for the purpose of preparing a semiannual report or certification. The regulation has been revised in Sec. 803.17 to clarify this point. 69. One comment stated that these provisions do not address the penalties for failure to comply. FDA intends to enforce this regulation and will take appropriate action against any firm or facility that does not comply. Violations may result in criminal prosecutions and/or civil remedies such as seizure, injunction, recall, and civil penalties. FDA's enforcement mechanisms and penalties for noncompliance are detailed in the preamble to the November 1991 tentative final rule (56 FR 60024 at 60029 through 60030). L. Files (Sec. 803.18) 70. Several comments complained that these requirements are overly broad, burdensome, and beyond the scope of the SMDA. FDA does not agree. Sections 519 and 701 of the act provide FDA the authority to require user facilities and manufacturers to maintain records to ensure that devices are not adulterated or misbranded. The file requirements are necessary to enable FDA to: (1) Further investigate potentially adulterated or misbranded devices to determine the cause of adverse events; (2) verify information received; and (3) ensure compliance with the regulations. These filing requirements will also enable the reporting entity to more readily identify causes of problems associated with devices so they can take appropriate actions. 71. Several comments expressed concern about public access and a loss of confidentiality stating that these will lead to increased lawsuits and, therefore, decreased reporting. Some comments suggested that only events reportable to FDA be kept in FDA accessible files. Others suggested that confidential materials and irrelevant data be excluded from the files. FDA has addressed issues related to confidentiality of reports it receives in section IV.C., comment 24 of this document. As stated therein, certain statutory and regulatory protections exist that prevent release of confidential information. FDA does not agree that only events that are ultimately determined to be reportable should be kept in MDR files. FDA must be able to audit files containing events that were determined not reportable to ensure such determinations were correct. 72. A few comments objected to FDA prescribing the method of record retention, preferring the use of individual systems. The agency disagrees. Effective and uniform regulatory enforcement is better assured by a standardized method of record retention. The agency believes that the method of record retention prescribed in this regulation does not impose an undue burden on the entities required to maintain such records. 73. One comment suggested that separate files be kept for devices and patients. FDA does not object to a reporting entity maintaining separate files for devices and patients provided that all required information is contained in the MDR files. 74. A few comments stated that a user facility should be required to keep files for a maximum of 2 years, rather than the expected life of the product, because some devices may have unusually long life expectancies. The agency agrees and has modified this section accordingly. It should be noted that device manufacturers, however, are still required to retain their records for 2 years or a period of time equivalent to the expected life of the device, whichever is greater. M. Who Must Register and Submit a Device List (Section 807.20) 75. One comment suggested that foreign manufacturers designate a U.S. agent to fulfill the registration and certification requirements. Another comment suggested that foreign manufacturers be permitted to register. Under Sec. 807.40 (21 CFR 807.40), foreign manufacturers are required to designate a U.S. agent to serve as an official correspondent, as well as to register and list their medical devices distributed in the United States, submit premarket notifications and ensure compliance with the MDR reporting requirements. In Sec. 807.40(a), FDA has changed the time allowed for foreign manufacturers to inform the agency of their designated U.S. agents, or a change in such agents, from 30 days to 5 days. FDA believes this is sufficient time to comply with this requirement. 76. Under Sec. 807.20 (21 CFR 807.20), an owner or operator is required to register its ``name, places of business, and all establishments.'' Under this regulation, FDA has required the registration of all locations that fit within the definition of ``establishment,'' which is defined under Sec. 807.3(a) (21 CFR 807.3(a)) as a location where devices are ``manufactured, assembled, or otherwise processed.'' Although FDA has authority under Sec. 807.20 to require the registration of ``places of business'' that are not ``establishments'' under initial registration and listing regulation that were issued in 1977, the agency previously has declined to exercise this authority. Under this regulation, FDA will use registration numbers in its data bases to process all manufacturer adverse event reports. Thus FDA must receive reports that originate from locations that may not be ``establishments'' and, therefore, have previously not had registration numbers. Accordingly, FDA is notifying manufacturers that upon the effective date of this final regulation, the agency will exercise its authority under Sec. 807.20, and require all locations that are MDR reporting sites to register because they are ``places of business'' under Sec. 807.20, regardless of whether they fit under the definition of ``establishment.'' V. Environmental Impact The agency has determined under 21 CFR 25.24(a)(8) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, [[Page 63594]] neither an environmental assessment nor an environmental impact statement is required. VI. Intergovernmental Partnership The agency has analyzed this rulemaking in accordance with the principles and criteria set forth in the Unfunded Mandate Reform Act (Pub. L. 104-4) and Executive Order 12875. Executive Order 12875 states that no agency or executive department shall promulgate any regulation that is not required by statute and that creates a mandate upon a State, local, or tribal government unless the Federal government supplies funds necessary to comply with the mandate, or the agency provides the Office of Management and Budget (OMB) a description of the agency's consultations with affected State, local, and tribal governments, the nature of their concerns, any written communications submitted to the agency by such units of government, and the agency's position supporting the need to issue the regulation containing the mandate. Executive Order 12875 does not apply to this final rule because the regulatory requirements that are applicable to government facilities are required by the provisions of the SMDA, as amended by the 1992 amendments. Moreover, many of the comments the agency received in response to the November 26, 1991, tentative final rule were from Federal, State, or local government facilities or from organizations representing these facilities. The agency believes this final rule is responsive to those comments. The agency has also examined the consistency of this final rule with the Unfunded Mandate Reform Act. The Unfunded Mandate Reform Act requires (in section 202) that agencies prepare an assessment of anticipated costs and benefits before proposing any rule that may result in an annual expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation). The Unfunded Mandate Reform Act does not apply to this final rule because it will not result in an annual expenditure by State, local, and tribal governments, in the aggregate, or by the private sector of $100 million. VII. Analysis of Impacts FDA has examined the impact of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the principles set out in the Executive Order. In addition, the final rule is not a significant regulatory action as defined by the Executive Order. Many comments stated that the provisions of the rule, as proposed, are overly burdensome, that the costs outweigh the benefits, and that the economic impact was underestimated and misleading. Several comments stated that the provisions constitute too great a burden for FDA, as well as for user facilities, distributors, and manufacturers. The agency does not agree. For the reasons stated in the preamble, including section IV.A., comment 1 of this document, FDA believes this regulation carefully balances the interests of public health with industry requirements. The agency also does not agree that the economic impact assessment was misleading. The cost projections contained in the proposed rule were based upon the information available to the agency at the time. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. The full economic impact assessment is on file at the Dockets Management Branch (address above). This rule is designed to: (1) Implement provisions of the SMDA regarding user facility reporting to FDA of deaths and serious injuries and illnesses related to medical devices and (2) amend the MDR regulations that require manufacturers to report deaths, serious injuries and malfunctions related to medical devices to FDA. A. Benefits The legislative history of the SMDA documents reports that device problems that occur in hospitals are rarely reported, despite full scale implementation of the current medical device reporting regulation. A 1986 Government Accounting Office report showed that less than 1 percent of device problems occurring in hospitals were reported directly to FDA. As a result, neither patients nor medical providers would have access to relevant safety information. This final rule requires user facilities to report device-related deaths and serious injuries promptly, and thus it expands the information base of FDA and the manufacturer for early detection of problems associated with medical devices. In addition to manufacturers, those required to report to FDA include device distributors, hospitals, nursing homes, ambulatory surgical facilities, and outpatient treatment and diagnostic facilities. As a result of this rule, FDA, patients, and medical providers will have access to relevant safety information not previously available. MDR reports alert FDA to life-threatening and other serious problems with medical devices that are on the market, and FDA then can address these problems through the appropriate mechanisms. Further, when the final rule is in place, FDA will begin to receive denominator, or baseline data, such as the number of a particular device manufactured, distributed, and in use in the previous year. This information will enable FDA to better perform trend analyses and determine the significance of a report or group of reports. Unfortunately, there are insufficient data available to quantify the benefits of the rule. The primary benefit of this rule is that it provides an early warning of device problems which is then evaluated together with other information and, if appropriate, followed by a corrective action such as the issuance of an FDA Safety Alert, recall, or other action. The agency believes the actions taken as a result of the information provided by MDR reports will provide benefits such as injuries prevented, lives saved, avoidance of hospitalization and outpatient treatment costs, and other possible benefits. Any quantification of benefits would require an estimation of both the number and seriousness of adverse events prevented by actions taken as the result of the evaluation of MDR reports. Thus the agency does not believe benefits can be quantified with any reliable accuracy. B. Nature of the Economic Impact This regulation will require certain device user facilities to develop, maintain, and implement procedures for reporting deaths and serious injuries related to medical devices. Some current MDR requirements for manufacturers are being eliminated or reduced, but manufacturers will now be required to develop and maintain written MDR procedures and implement new reporting requirements, including the submission of baseline reports and annual updates and annual certification. In addition, foreign manufacturers will be required to designate an agent in the United States that will be responsible [[Page 63595]] for submitting required documents for complying with the MDR reporting requirements and for related documentation. C. Impact Assessment Based on the cost analysis, the economic impact on manufacturers, U.S. agents for foreign manufacturers, and users of medical devices will not exceed the $100 million threshold established under Executive Order 12866. Annualized one-time costs of about $9.1 million will be incurred by industry for establishing and/or documenting procedures for data collection and reporting. In addition, the annual cost of user reporting is estimated to be $31.7 million, for a total annualized industry cost of $40.8 million. An estimated 51,000 additional death and injury reports are expected as a result of adverse incidents that must be reported under this rule. This is in line with the Congressional Budget Office estimate of 40,000 reports. These incidents generate investigation, data analyses and summaries, and additional reporting requirements. Based on the above estimates, this translates to an average cost per adverse report of $799. 1. User Facility Costs Table 1 summarizes the total incremental initial and recurring costs of the reporting requirements for user facilities. These estimates are based on cost data from the Center for Devices and Radiological Health's draft report to Congress, entitled ``The Evaluation of Medical Device User Facility Reporting Requirements'', 1994. Components of one-time costs include developing procedures and modifying forms for reporting and training personnel. The most significant one-time costs are $3.0 million for developing procedures and $2.6 million for ``other'' startup costs. The total annualized one- time cost to user facilities is estimated to be $8.9 million. Table 1.--Total Costs to User Facilities by Type of Facility [millions of dollars] ---------------------------------------------------------------------------------------------------------------- Number of One-time Facility type facilities cost Annualized Annual Total ------------------------------------------------------------------------------\1\------------------------------- Hospitals.................................... 6,738 7.9 1.9 7.0 8.9 Nursing homes................................ 25,648 12.7 3.1 5.3 8.4 Ambulatory surgical.......................... 1,300 0.7 0.2 0.7 0.9 Outpatient diagnostic........................ 7,578 3.3 0.8 0.7 1.5 Outpatient treatment......................... 4,041 2.5 0.6 1.4 2.0 Emergency medical service.................... 15,600 9.5 2.3 4.1 6.4 ------------------------------------------------------------------ Total.................................. 60,905 36.6 8.9 19.3 28.2 ---------------------------------------------------------------------------------------------------------------- \1\ Annualized over 5 years at a discount rate of 7 percent. (Numbers may not add due to rounding.) Annual costs include investigation of the event, reporting the event, preparing semiannual reports, and related computer, and other costs. The total annual cost to user facilities is $19.3 million. Hospitals and nursing homes incur about two- thirds of this cost at $7.0 million and $5.3 million, respectively. Major components of annual cost include $5.4 million to investigate and to prepare the initial reports. Semiannual reports are required only if a facility has a reportable event, and are estimated to cost $59,000. The most significant costs are for computer and other costs at $14.8 million. The total first-year costs to user facilities is $28.2 million. 2. Manufacturer and U.S. Agent for Foreign Manufacturer Costs Manufacturers are currently required under the current good manufacturing practices regulation to investigate complaints and analyze device failures. Manufacturers will now be required to document and maintain their MDR related procedures. The vast majority of manufacturers already have such written procedures in place. Incremental one-time costs for documenting these procedures will be $105 thousand. Foreign manufacturers will incur additional one-time costs of $662 thousand to select an agent and notify FDA. Annualized at 7 percent over 5 years, this translates to $187 thousand per year. Manufacturers must also comply with the new reporting requirements. Table 2 presents the expected annual cost of reporting by type of facility and type of report. The major components of annual cost include the followup and reporting of additional adverse medical device events and the submission of baseline reports. MDR followup on user and distributor reports and completion of information on Form 3500A is expected to cost manufacturers $11.1 million annually for the estimated 51,000 reports from user facilities and distributors. The cost of 8,000 new baseline reports and 12,000 updates will be $598 thousand. Table 2.--Annual Cost of Reporting ---------------------------------------------------------------------------------------------------------------- Cost Number of Total cost Type of facility Type of report (dollars) reports ($000) ---------------------------------------------------------------------------------------------------------------- All manufacturers......................... Followup MDR's from user/ 217.60 51,000 11,098 distributor facilities. Baseline report.............. 54.40 8,000 435 Baseline update.............. 13.60 12,000 163 Five-day report.............. 233.60 100 23 Annual certification......... 26.00 12,145 316 Foreign only.............................. Fees for MDR reporting....... ........... ........... 134 Fees for 510(k) filing....... 110.08 510 56 -------------------------------------- (All manufacturers-Total ).......... ............................. ........... ........... 12,225 ====================================== U.S. agents for foreign manufacturers..... Register and list............ 16.64 4,812 80 [[Page 63596]] Notify and document MDR's.... 7.80 5,750 45 -------------------------------------- (U.S. agents for foreign ............................. ........... ........... 125 manufacturers-Total). ====================================== Total............................... ............................. ........... ........... 12,350 ---------------------------------------------------------------------------------------------------------------- In addition, domestic manufacturers and U.S. agents for foreign manufacturers will be required to certify annually the number of reportable events that have occurred. This is a formality in terms of data collection and reporting and is expected to cost $316 thousand. Foreign manufacturers will incur a fee of $190 thousand for reporting services conducted by their U.S. agents. Annual costs to U.S. agents are $125 thousand for registering and listing their foreign manufacturers establishments and products and for complying with reporting requirements. Previously, foreign manufacturers were required to submit premarket notifications or have their initial distributor in the United States do so. Now, U.S. agents will be required to submit premarket notifications for foreign manufacturers. This represents a transfer of existing requirements and therefore, no increase in cost. 3. Total Cost to Industry Table 3 presents a summary of the total annual costs to industry. Costs are $28.2 million for user facilities, $12.4 million for manufacturers, and $125 thousand for U.S. agents for foreign manufacturers, for a total annual cost to industry of $40.8 million. Table 3.--Total Annualized Cost to Industry [in millions of dollars] ------------------------------------------------------------------------ One-time Industry \1\ Annual Total ------------------------------------------------------------------------ User Facilities........................... 8.93 19.31 28.24 Manufacturers............................. 0.19 12.22 12.41 U.S. agents for foreign manufactuers...... ........ 0.13 0.13 ----------------------------- Total............................... 9.12 31.66 40.77 ------------------------------------------------------------------------ \1\ Annualized over 5 years at a discount rate of 7 percent. (Numbers may not add due to rounding.) 4. Small Business Impacts There is little likelihood that there will be a significant impact on small facilities. The one-time start-up costs range from $437 to $1,629 for user facilities, depending on facility type. Annualized at 7 percent for 5 years, these costs range from $107 to $397 for user facilities. In addition, estimates of the annual number of additional medical device events attributable to this regulation are about 51,000. Because there are nearly 61,000 user facilities, this averages out to about .8 serious events per facility attributable to the user reporting rule at an annual cost of $400 per event. Similarly, small businesses in the medical device manufacturing industry will not be significantly affected, although the industry has a substantial number of small facilities, with about 65 percent of the establishments having fewer than 50 employees. No more than 22 percent of the anticipated $12 million annual impact of these regulations on manufacturers would be attributable to small establishments, or about $2.7 million per year. Because there are about 7,300 small medical device establishments (including foreign manufacturers), the average impact on one small establishment should be less than $338 annually. Assuming that all of the approximately 4,800 U.S. agents are small, on average, the $125 thousand impact on any one establishment would be $26 annually. VIII. Paperwork Reduction Act of 1995 This final rule contains information collections which are subject to review by OMB under the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The title, description, and respondent description of the information collections are shown below and an estimate of the annual recordkeeping and periodic reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Title: Reporting and recordkeeping requirements for user facilities and manufacturers of medical devices under the Safe Medical Devices Act of 1990 (SMDA) and the Medical Device Amendments of 1992 (1992 Amendments)(General requirements). Description: This regulation implements provisions of the SMDA and the 1992 amendments regarding user facility reporting of deaths and serious injuries related to medical devices. This regulation also amends regulations regarding device manufacturer reporting of deaths, serious injuries, and certain malfunctions related to medical devices. The purpose of these changes is to improve the protection of the public health while also reducing the regulatory burden on reporting entities. Description of Respondents: Businesses or other for profit organizations, nonprofit organizations, Federal, State, and local governments. Table 4.--Estimated Annual Burden for Reporting ---------------------------------------------------------------------------------------------------------------- Number of Number of responses Total Hours per CFR section respondents per annual response Total hours respondent responses ---------------------------------------------------------------------------------------------------------------- 803.19......................................... 100 1.0 100 3.0 300 [[Page 63597]] 803.30(a)...................................... 700 1.0 700 3.0 2,100 803.30(b)...................................... 20,000 1.5 30,000 3.0 90,000 803.33......................................... 2,000 1.0 2,000 1.0 2,000 803.50......................................... 1,250 40.0 50,000 0.5 25,000 803.53......................................... 100 1.0 100 0.5 50 803.55......................................... 1,000 20.0 20,000 \1\ 1.1 22,000 803.56......................................... 500 20.0 10,000 1.0 10,000 803.57......................................... 12,000 1.0 12,000 1.0 12,000 803.58......................................... 5,000 1.0 5,000 1.0 5,000 ---------------------------------------------------------------- Total.................................... ........... ........... ........... ........... 168,450 ---------------------------------------------------------------------------------------------------------------- \1\ Although an initial submission will take an estimated 2 hours to complete, the annual update will take only .5 hours. The average hours per response is therefore 1.1, as reflected here. Table 5.--Estimated Annual Burden for Recordkeeping ------------------------------------------------------------------------ Number of Hours per CFR section recordkeepers recordkeeper Total hours ------------------------------------------------------------------------ 803.18(c)..................... 36,639 0.25 9,160 803.18(e)..................... 625 16.00 10,000 ----------------------------------------- Total................... ............. ............ 19,160 ------------------------------------------------------------------------ Although the November 26, 1991, tentative final rule provided a 60- day comment period (extended to 90 days in the January 24, 1992, Federal Register, 57 FR 2861), and this final rule is based on the comments received, FDA Form 3419 (semiannual report), FDA Form 3417 (baseline report), and FDA Form 3381 (annual certification) have not been previously available to OMB or the public for review. Therefore, as required by section 3507(d) of the Paperwork Reduction Act of 1995, FDA has submitted a copy of this final rule to OMB for its review of these information collection requirements. In addition, the agency solicits public comment on the information collection requirements in order to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Individuals and organizations may submit comments on the information collection requirements by January 10, 1996, and should direct them to FDA's Dockets Management Branch (address above) and to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., rm. 10235, 725 17th St. NW., Washington, DC 20503, Attention: Desk Officer for FDA. Persons are not required to respond to a collection of information unless it displays a currently valid OMB control number. This final rule contains information collection requirements which have been approved under OMB no. 0910-0059 and which expires on March 31, 1996. FDA will publish a notice in the Federal Register prior to the effective date of this final rule of OMB's decision to approve, modify or disapprove the information collection requirements. List of Subjects 21 CFR Part 803 Imports, Medical devices, Reporting and recordkeeping requirements. 21 CFR Part 807 Confidential business information, Medical devices, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs, chapter I of title 21 of the Code of Federal Regulations is amended as follows: 1. Part 803 is revised to read as follows: PART 803--MEDICAL DEVICE REPORTING Subpart A--General Provisions Sec. 803.1 Scope. 803.3 Definitions. 803.9 Public availability of reports. 803.10 General description of reports required from user facilities and manufacturers. 803.11 Obtaining the forms. 803.12 Where to submit reports. 803.13 English reporting requirement. 803.14 Electronic reporting. 803.15 Requests for additional information. 803.16 Disclaimers. 803.17 Written MDR procedures. 803.18 Files. 803.19 Exemptions, variances, and alternative reporting requirements. Subpart B--Generally Applicable Requirements for Individual Adverse Event Reports 803.20 How to report. 803.21 Reporting codes. 803.22 When not to file. [[Page 63598]] Subpart C--User Facility Reporting Requirements 803.30 Individual adverse event reports; user facilities. 803.32 Individual adverse event report data elements. 803.33 Semiannual reports. Subpart D--[Reserved] Subpart E--Manufacturer Reporting Requirements 803.50 Individual adverse event reports; manufacturers. 803.52 Individual adverse event report data elements. 803.53 Five-day reports. 803.55 Baseline reports. 803.56 Supplemental reports. 803.57 Annual certification. 803.58 Foreign manufacturers. Authority: Secs. 502, 510, 519, 520, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 360j, 371, 374). Subpart A--General Provisions Sec. 803.1 Scope. (a) This part establishes requirements for medical device reporting. Under this part, device user facilities and manufacturers must report deaths and serious injuries to which a device has or may have caused or contributed, and must establish and maintain adverse event files. Manufacturers are also required to report certain device malfunctions and submit an annual report to FDA certifying that the correct number of medical device reports were filed during the previous 12-month period or, alternatively, that no reports were required during that same time period. These reports will assist FDA in protecting the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use. (b) This part supplements and does not supersede other provisions of this subchapter, including the provisions of part 820 of this chapter. (c) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of title 21, unless otherwise noted. Sec. 803.3 Definitions. (a) Act means the Federal Food, Drug, and Cosmetic Act. (b) Ambulatory surgical facility (ASF) means a distinct entity that operates for the primary purpose of furnishing same day outpatient surgical services to patients. An ASF may be either an independent entity (i.e., not a part of a provider of services or any other facility) or operated by another medical entity (e.g., under the common ownership, licensure or control of an entity). An ASF is subject to this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or regardless of whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the ASF must report that event regardless of the nature or location of the medical service provided by the ASF. (c) Become aware means that an employee of the entity required to report has acquired information reasonably suggesting a reportable adverse event has occurred. Device user facilities are considered to have ``become aware'' when medical personnel, as defined in paragraph (r) of this section, who are employed by or otherwise formally affiliated with the facility, acquire such information about a reportable event. Manufacturers are considered to have ``become aware'' of an event when: (1) Any employee becomes aware of a reportable event that is required to be reported within 30 days, or that is required to be reported within 5 days pursuant to a written request from FDA under 803.53(b); and (2) Any employee, who is a person with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or a person whose duties relate to the collection and reporting of adverse events, becomes aware that a reportable MDR event or events, from any information, including any trend analysis, necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health. (d) Caused or contributed means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of: (1) Failure; (2) Malfunction; (3) Improper or inadequate design; (4) Manufacture; (5) Labeling; or (6) User error. (e) (1) Device family means a group of one or more devices manufactured by or for the same manufacturer and having the same: (i) Basic design and performance characteristics related to device safety and effectiveness, (ii) Intended use and function, and (iii) Device classification and product code. (2) Devices that differ only in minor ways not related to safety or effectiveness can be considered to be in the same device family. Factors such as brand name and common name of the device and whether the devices were introduced into commercial distribution under the same 510(k) or premarket approval application (PMA), may be considered in grouping products into device families. (f) Device user facility means a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as defined in paragraphs (l), (b), (s), (t), and (u), respectively, of this section, which is not a ``physician's office,'' as defined in paragraph (w) of this section. School nurse offices and employee health units are not device user facilities. (g) [Reserved] (h) [Reserved] (i) Expected life of a device (required on the manufacturer's baseline report) means the time that a device is expected to remain functional after it is placed into use. Certain implanted devices have specified ``end of life'' (EOL) dates. Other devices are not labeled as to their respective EOL, but are expected to remain operational through maintenance, repair, upgrades, etc., for an estimated period of time. (j) FDA means the Food and Drug Administration. (k) Five-day report means a medical device report that must be submitted by a manufacturer to FDA pursuant to Sec. 803.53, on FDA Form 3500A or electronic equivalent as approved under Sec. 803.14, within 5 work days. (l) Hospital means a distinct entity that operates for the primary purpose of providing diagnostic, therapeutic (medical, occupational, speech, physical, etc.), surgical and other patient services for specific and general medical conditions. Hospitals include general, chronic disease, rehabilitative, psychiatric, and other special-purpose facilities. A hospital may be either independent (e.g., not a part of a provider of services or any other facility) or may be operated by another medical entity (e.g., under the common ownership, licensure or control of another entity). A hospital is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the hospital must report that event regardless of the nature or location of the medical service provided by the hospital. (m) Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended [[Page 63599]] performance of a device refers to the intended use for which the device is labeled or marketed, as defined in Sec. 801.4 of this chapter. (n) Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who: (1) Repackages or otherwise changes the container, wrapper or labeling of a device in furtherance of the distribution of the device from the original place of manufacture; (2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications; (3) Manufactures components or accessories which are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or (4) Is the U.S. agent of a foreign manufacturer. (o) Manufacturer report number means the number that uniquely identifies each individual adverse event report submitted by a manufacturer. This number consists of three parts as follows: (1) The FDA registration number for the manufacturing site of the reported device. (If the manufacturing site does not have a registration number, FDA will assign a temporary number until the site is officially registered. The manufacturer will be informed of the temporary number.); (2) The four-digit calendar year in which the report is submitted; and (3) The five-digit sequence number of the reports submitted during the year, starting with 00001. (For example, the complete number will appear 1234567-1995-00001.) (p) MDR means medical device report. (q) MDR reportable event (or reportable event) means: (1) An event about which user facilities become aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or (2) An event about which manufacturers have received or become aware of information that reasonably suggests that one of their marketed devices: (i) May have caused or contributed to a death or serious injury; or (ii) Has malfunctioned and that the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. (r) Medical personnel, as used in this part, means an individual who: (1) Is licensed, registered, or certified by a State, territory, or other governing body, to administer health care; (2) Has received a diploma or a degree in a professional or scientific discipline; (3) Is an employee responsible for receiving medical complaints or adverse event reports; or (4) Is a supervisor of such persons. (s)(1) Nursing home means an independent entity (i.e., not a part of a provider of services or any other facility) or one operated by another medical entity (e.g., under the common ownership, licensure, or control of an entity) that operates for the primary purpose of providing: (i) Skilled nursing care and related services for persons who require medical or nursing care; (ii) Hospice care to the terminally ill; or (iii) Services for the rehabilitation of the injured, disabled, or sick. (2) A nursing home is subject to this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the nursing home must report that event regardless of the nature, or location of the medical service provided by the nursing home. (t)(1) Outpatient diagnostic facility means a distinct entity that: (i) Operates for the primary purpose of conducting medical diagnostic tests on patients; (ii) Does not assume ongoing responsibility for patient care; and (iii) Provides its services for use by other medical personnel. (Examples include diagnostic radiography, mammography, ultrasonography, electrocardiography, magnetic resonance imaging, computerized axial tomography and in-vitro testing). (2) An outpatient diagnostic facility may be either independent (i.e., not a part of a provider of services or any other facility) or operated by another medical entity (e.g., under the common ownership, licensure, or control of an entity). An outpatient diagnostic facility is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatient diagnostic facility must report that event regardless of the nature or location of the medical service provided by the outpatient diagnostic facility. (u) (1) Outpatient treatment facility means a distinct entity that operates for the primary purpose of providing nonsurgical therapeutic (medical, occupational, or physical) care on an outpatient basis or home health care setting. Outpatient treatment facilities include ambulance providers, rescue services, and home health care groups. Examples of services provided by outpatient treatment facilities include: Cardiac defibrillation, chemotherapy, radiotherapy, pain control, dialysis, speech or physical therapy, and treatment for substance abuse. (2) An outpatient treatment facility may be either independent (i.e., not a part of a provider of services or any other facility) or operated by another medical entity (e.g., under the common ownership, licensure, or control of an entity). An outpatient treatment facility is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatient treatment facility must report that event regardless of the nature or location of the medical service provided by the outpatient treatment facility. (v) Patient of the facility means any individual who is being diagnosed or treated and/or receiving medical care at or under the control or authority of the facility. For the purposes of this part, the definition encompasses employees of the facility or individuals affiliated with the facility, who in the course of their duties suffer a device-related death or serious injury that has or may have been caused or contributed to by a device used at the facility. (w) Physician's office means a facility that operates as the office of a physician or other health care professional (e.g., dentist, chiropractor, optometrist, nurse practitioner, school nurse offices, school clinics, employee health clinics, or free-standing care units) for the primary purpose of examination, evaluation, and treatment or referral of patients. A physician's office may be independent, a group practice, or part of a Health Maintenance Organization. (x) [Reserved] (y) Remedial action means, for the purposes of this subpart, any action other than routine maintenance or servicing, of a device where such action is necessary to prevent recurrence of a reportable event. (z) [Reserved] (aa)(1) Serious injury means an injury or illness that: [[Page 63600]] (i) Is life-threatening; (ii) Results in permanent impairment of a body function or permanent damage to body structure; or (iii) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. (2) Permanent means, for purposes of this subpart, irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage. (bb) Shelf life, as required on the manufacturer's baseline report, means the maximum time a device will remain functional from the date of manufacture until it is used in patient care. Some devices have an expiration date on their labeling indicating the maximum time they can be stored before losing their ability to perform their intended function. (cc) [Reserved] (dd)(1) User facility report number means the number that uniquely identifies each report submitted by a user facility to manufacturers and FDA. This number consists of three parts as follows: (i) The user facility's 10-digit Health Care Financing Administration (HCFA) number (if the HCFA number has fewer than 10 digits, fill the remaining spaces with zeros); (ii) The four-digit calendar year in which the report is submitted; and (iii) The four-digit sequence number of the reports submitted for the year, starting with 0001. (For example, a complete number will appear as follows: 1234560000-1995-0001.) (2) If a facility has more than one HCFA number, it must select one that will be used for all of its MDR reports. If a facility has no HCFA number, it should use all zeros in the appropriate space in its initial report (e.g., 0000000000-1995-0001) and FDA will assign a number for future use. The number assigned will be used in FDA's record of that report and in any correspondence with the user facility. All zeros should be used subsequent to the first report if the user does not receive FDA's assigned number before the next report is submitted. If a facility has multiple sites, the primary site can report centrally and use one reporting number for all sites if the primary site provides the name, address and HCFA number for each respective site. (ee) Work day means Monday through Friday, excluding Federal holidays. Sec. 803.9 Public availability of reports. (a) Any report, including any FDA record of a telephone report, submitted under this part is available for public disclosure in accordance with part 20 of this chapter. (b) Before public disclosure of a report, FDA will delete from the report: (1) Any information that constitutes trade secret or confidential commercial or financial information under Sec. 20.61 of this chapter; (2) Any personal, medical, and similar information (including the serial number of implanted devices), which would constitute an invasion of personal privacy under Sec. 20.63 of this chapter. FDA will disclose to a patient who requests a report, all the information in the report concerning that patient, as provided in Sec. 20.61 of this chapter; and (3) Any names and other identifying information of a third party voluntarily submitting an adverse event report. (c) FDA may not disclose the identity of a device user facility which makes a report under this part except in connection with: (1) An action brought to enforce section 301(q) of the act, including the failure or refusal to furnish material or information required by section 519 of the act; (2) A communication to a manufacturer of a device which is the subject of a report required by a user facility under Sec. 803.30; (3) A disclosure relating to a manufacturer or distributor adverse event report that is required under section 519(a) of the act; or (4) A disclosure to employees of the Department of Health and Human Services, to the Department of Justice, or to the duly authorized committees and subcommittees of the Congress. Sec. 803.10 General description of reports required from user facilities and manufacturers. (a) Device user facilities. User facilities must submit the following reports, which are described more fully in subpart C of this part. (1) User facilities must submit MDR reports of individual adverse events within 10 days after the user facility becomes aware of an MDR reportable event as described in Secs. 803.30 and 803.32. (i) User facilities must submit reports of device-related deaths to FDA and to the manufacturer, if known. (ii) User facilities must submit reports of device-related serious injuries to manufacturers, or to FDA, if the manufacturer is unknown. (2) User facilities must submit semiannual reports as described in Sec. 803.33. (b) [Reserved] (c) Device manufacturers. Manufacturers must submit the following reports as described more fully in subpart E of this part: (1) MDR reports of individual adverse events within 30 days after the manufacturer becomes aware of a reportable death, serious injury, or malfunction as described in Secs. 803.50 and 803.52. (2) MDR reports of individual adverse events within 5 days of: (i) Becoming aware that a reportable MDR event requires remedial action to prevent an unreasonable risk of substantial harm to the public health or, (ii) Becoming aware of an MDR reportable event for which FDA has made a written request, as described in Sec. 803.53. (3) Annual baseline reports as described in Sec. 803.55. (4) Supplemental reports if they obtain information that was not provided in an initial report as described in Sec. 803.56. (5) Annual certification to FDA of the number of MDR reports filed during the preceding year as described in Sec. 803.57. Sec. 803.11 Obtaining the forms. User facilities and manufacturers must submit all reports of individual adverse events on FDA Form 3500A (MEDWATCH form) or in an electronic equivalent as approved under Sec. 803.14. This form and all other forms referenced in this section can also be obtained from the Consolidated Forms and Publications Office, Washington Commerce Center, 3222 Hubbard Rd., Landover, MD 20785, or from the Division of Small Manufacturers Assistance, Office of Health and Industry Programs, Center for Devices and Radiological Health, 1350 Piccard Dr. (HFZ-220), Rockville, MD 20850, telephone facsimile (FAX) 301-443-8818. FDA Form 3500A may also be obtained from the Food and Drug Administration, MEDWATCH (HF-2), 5600 Fishers Lane, rm. 9-57, Rockville, MD 20850, 301- 443-0117. Sec. 803.12 Where to submit reports. (a) Any written report or additional information required under this part shall be submitted to: Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Reporting, PO Box 3002, Rockville, MD 20847-3002. (b) Each report and its envelope shall be specifically identified, e.g., ``User Facility Report,'' ``SemiAnnual Report,'' ``Manufacturer Report,'' ``5-Day Report,'' ``Baseline Report,'' etc. (c) If an entity is confronted with a public health emergency, this can be brought to FDA's attention by contacting the FDA Emergency Operations Branch [[Page 63601]] (HFC-162), Office of Regional Operations, at 301-443-1240, and should be followed by the submission of a FAX report to 301-443-3757. (d) A voluntary telephone report may be submitted to, or information regarding voluntary reporting may be obtained from, the MEDWATCH hotline at 800-FDA-1088. Sec. 803.13 English reporting requirement. (a) All reports required in this part which are submitted in writing or electronic equivalent shall be submitted to FDA in English. (b) All reports required in this part which are submitted on an electronic medium shall be submitted to FDA in a manner consistent with Sec. 803.14. Sec. 803.14 Electronic reporting. (a) Any report required by this part may be submitted electronically with prior written consent from FDA. Such consent is revocable. Electronic report submissions include alternative reporting media (magnetic tape, disc, etc.) and computer-to-computer communication. (b) Any electronic report meeting electronic reporting standards, guidelines, or other procedures developed by the agency for MDR reporting will be deemed to have prior approval for use. Sec. 803.15 Requests for additional information. (a) FDA may determine that protection of the public health requires additional or clarifying information for medical device reports submitted to FDA under this part. In these instances, and in cases when the additional information is beyond the scope of FDA reporting forms or is not readily accessible, the agency will notify the reporting entity in writing of the additional information that is required. (b) Any request under this section shall state the reason or purpose for which the information is being requested, specify the date that the information is to be submitted and clearly relate the request to a reported event. All verbal requests will be confirmed in writing by the agency. Sec. 803.16 Disclaimers. A report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity need not admit and may deny that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a reportable event. Sec. 803.17 Written MDR procedures. User facilities and manufacturers shall develop, maintain, and implement written MDR procedures for the following: (a) Internal systems that provide for: (1) Timely and effective identification, communication, and evaluation of events that may be subject to medical device reporting requirements; (2) A standardized review process/procedure for determining when an event meets the criteria for reporting under this part; and (3) Timely transmission of complete medical device reports to FDA and/or manufacturers; (b) Documentation and recordkeeping requirements for: (1) Information that was evaluated to determine if an event was reportable; (2) All medical device reports and information submitted to FDA and manufacturers; (3) Any information that was evaluated for the purpose of preparing the submission of semiannual reports or certification; and (4) Systems that ensure access to information that facilitates timely followup and inspection by FDA. Sec. 803.18 Files. (a) User facilities and manufacturers shall establish and maintain MDR event files. All MDR event files shall be prominently identified as such and filed to facilitate timely access. (b) (1) For purposes of this part, ``MDR event files'' are written or electronic files maintained by user facilities and manufacturers. MDR event files may incorporate references to other information, e.g., medical records, patient files, engineering reports, etc., in lieu of copying and maintaining duplicates in this file. MDR event files must contain: (i) Information in the possession of the reporting entity or references to information related to the adverse event, including all documentation of the entity's deliberations and decisionmaking processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable under this part. (ii) Copies of all MDR forms, as required by this part, and other information related to the event that was submitted to FDA and other entities (e.g., a distributor or manufacturer). (2) User facilities and manufacturers shall permit any authorized FDA employee during all reasonable times to access, to copy, and to verify the records required by this part. (c) User facilities shall retain an MDR event file relating to an adverse event for a period of 2 years from the date of the event. Manufacturers shall retain an MDR event file relating to an adverse event for a period of 2 years from the date of the event or a period of time equivalent to the expected life of the device, whichever is greater. MDR event files must be maintained for the time periods described in this paragraph even if the device is no longer distributed. (d) [Reserved] (e) The manufacturer may maintain MDR event files as part of its complaint file, under Sec. 820.198 of this chapter, provided that such records are prominently identified as MDR reportable events. A report submitted under this subpart A shall not be considered to comply with this part unless the event has been evaluated in accordance with the requirements of Secs. 820.162 and 820.198 of this chapter. MDR files shall contain an explanation of why any information required by this part was not submitted or could not be obtained. The results of the evaluation of each event are to be documented and maintained in the manufacturer's MDR event file. Sec. 803.19 Exemptions, variances, and alternative reporting requirements. (a) The following persons are exempt from the reporting requirements under this part. (1) An individual who is a licensed practitioner who prescribes or administers devices intended for use in humans and who manufactures or imports devices solely for use in diagnosing and treating persons with whom the practitioner has a ``physician- patient'' relationship. (2) An individual who manufactures devices intended for use in humans solely for such person's use in research or teaching and not for sale, including any person who is subject to alternative reporting requirements under the investigational device exemption regulations, parts 812 and 813 of this chapter, which require reporting of all adverse device effects. (3) Dental laboratories, or optical laboratories. (b) Manufacturers or user facilities may request exemptions or variances from any or all of the reporting requirements in this part. The request shall be in writing and include information necessary to identify the [[Page 63602]] firm and device, a complete statement of the request for exemption, variance, or alternative reporting, and an explanation why the request is justified. (c) FDA may grant in writing, to a manufacturer or user facility, an exemption, variance or alternative from, or to, any or all of the reporting requirements in this part and may change the frequency of reporting to quarterly, semiannually, annually, or other appropriate time period. These modifications may be initiated by a request as specified in this section, or at the discretion of FDA. When granting such modifications, FDA may impose other reporting requirements to ensure the protection of public health. (d) FDA may revoke or modify in writing an exemption, variance, or alternative reporting requirements if FDA determines that protection of the public health justifies the modification or a return to the requirements as stated in this part. (e) Firms granted a reporting modification by FDA shall provide any reports or information required by that approval. The conditions of the approval will replace and supersede the reporting requirement specified in this part until such time that FDA revokes or modifies the alternative reporting requirements in accordance with paragraph (d) of this section. Subpart B--Generally Applicable Requirements for Individual Adverse Event Reports Sec. 803.20 How to report. (a) Description of form. There are two versions of the MEDWATCH form for individual reports of adverse events. FDA Form 3500 is available for use by health professionals and consumers for the submission of voluntary reports regarding FDA-regulated products. FDA Form 3500A is the mandatory reporting form to be used for submitting reports by user facilities and manufacturers of FDA-regulated products. The form has sections that must be completed by all reporters and other sections that must be completed only by the user facility or manufacturer. (1) The front of FDA Form 3500A is to be filled out by all reporters. The front of the form requests information regarding the patient, the event, the device and ``initial reporter'' (i.e., the first person or entity that submitted the information to the user facility, manufacturer, or distributor). (2) The back part of the form contains sections to be completed by user facilities and manufacturers. User facilities must complete section F; device manufacturers must complete sections G and H. Manufacturers are not required to recopy information submitted to them on a Form 3500A unless the information is being copied onto an electronic medium. If the manufacturer corrects or supplies information missing from the other reporter's 3500A form, it should attach a copy of that form to the manufacturer's report form. If the information from the other reporter's 3500A form is complete and correct, the manufacturer can fill in the remaining information on the same form. (b) Reporting standards. (1) User facilities are required to submit MDR reports to: (i) The device manufacturer and to FDA within 10 days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a death; or (ii) The manufacturer within 10 days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury. Such reports shall be submitted to FDA if the device manufacturer is not known. (2) [Reserved] (3) Manufacturers are required to submit MDR reports to FDA: (i) Within 30 days of becoming aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury; or (ii) Within 30 days of becoming aware of information that reasonably suggests a device has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause a death or serious injury if the malfunction were to recur; or (iii) Within 5 days if required by Sec. 803.53. (c) Information that reasonably suggests a reportable event occurred (1) Information that reasonably suggests that a device has or may have caused or contributed to an MDR reportable event (i.e., death, serious injury, and, for manufacturers, a malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur) includes any information, such as professional, scientific or medical facts and observations or opinions, that would reasonably suggest that a device has caused or may have caused or contributed to a reportable event. (2) Entities required to report under this part do not have to report adverse events for which there is information that would cause a person who is qualified to make a medical judgment (e.g., a physician, nurse, risk manager, or biomedical engineer) to reach a reasonable conclusion that a device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur. Information which leads the qualified person to determine that a device-related event is or is not reportable must be contained in the MDR event files, as described in Sec. 803.18. Sec. 803.21 Reporting codes. (a) FDA has developed a MEDWATCH Mandatory Reporting Form Coding Manual for use with medical device reports. This manual contains codes for hundreds of adverse events for use with FDA Form 3500A. The coding manual is available from the Division of Small Manufacturer Assistance, Center for Devices and Radiological Health, 1350 Piccard Dr., Rockville, MD 20850, FAX 301-443-8818. (b) FDA may use additional coding of information on the reporting forms or modify the existing codes on an ad hoc or generic basis. In such cases, FDA will ensure that the new coding information is available to all reporters. Sec. 803.22 When not to file. (a) Only one medical device report from the user facility or manufacturer is required under this part if the reporting entity becomes aware of information from multiple sources regarding the same patient and same event. (b) A medical device report that would otherwise be required under this section is not required if: (1) The user facility or manufacturer determines that the information received is erroneous in that a device-related adverse event did not occur. Documentation of such reports shall be retained in MDR files for time periods specified in Sec. 803.18. (2) The manufacturer determines that the device was manufactured by another manufacturer. Any reportable event information that is erroneously sent to a manufacturer shall be forwarded to FDA, with a cover letter explaining that the device in question was not manufactured by that firm. Subpart C--User Facility Reporting Requirements Sec. 803.30 Individual adverse event reports; user facilities. (a) Reporting standard. A user facility shall submit the following reports to the manufacturer or to FDA, or both, as specified below: (1) Reports of death. Whenever a user facility receives or otherwise becomes aware of information, from any source, that reasonably suggests that a device [[Page 63603]] has or may have caused or contributed to the death of a patient of the facility, the facility shall as soon as practicable, but not later than 10 work days after becoming aware of the information, report the information required by Sec. 803.32 to FDA, on FDA Form 3500A, or an electronic equivalent as approved under Sec. 803.14, and if the identity of the manufacturer is known, to the device manufacturer. (2) Reports of serious injury. Whenever a user facility receives or otherwise becomes aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of the facility, the facility shall, as soon as practicable but not later than 10 work days after becoming aware of the information, report the information required by Sec. 803.32, on FDA Form 3500A or electronic equivalent, as approved under Sec. 803.14, to the manufacturer of the device. If the identity of the manufacturer is not known, the report shall be submitted to FDA. (b) Information that is reasonably known to user facilities. User facilities must provide all information required in this subpart C that is reasonably known to them. Such information includes information found in documents in the possession of the user facility and any information that becomes available as a result of reasonable followup within the facility. A user facility is not required to evaluate or investigate the event by obtaining or evaluating information that is not reasonably known to it. Sec. 803.32 Individual adverse event report data elements. User facility reports shall contain the following information, reasonably known to them as described in 803.30(b), which corresponds to the format of FDA Form 3500A: (a) Patient information (Block A) shall contain the following: (1) Patient name or other identifier; (2) Patient age at the time of event, or date of birth; (3) Patient gender; and (4) Patient weight. (b) Adverse event or product problem (Block B) shall contain the following: (1) Identification of adverse event or product problem; (2) Outcomes attributed to the adverse event, e.g., death; or serious injury, that is: (i) Life threatening injury or illness; (ii) Disability resulting in permanent impairment of a body function or permanent damage to a body structure; or (iii) Injury or illness that requires intervention to prevent permanent impairment of a body structure or function; (3) Date of event; (4) Date of report by the initial reporter; (5) Description of event or problem, including a discussion of how the device was involved, nature of the problem, patient followup or required treatment, and any environmental conditions that may have influenced the event; (6) Description of relevant tests including dates and laboratory data; and (7) Description of other relevant history including pre- existing medical conditions. (c) Device information (Block D) shall contain the following: (1) Brand name; (2) Type of device; (3) Manufacturer name and address; (4) Operator of the device (health professional, patient, lay user, other); (5) Expiration date; (6) Model number, catalog number, serial number, lot number, or other identifying number; (7) Date of device implantation (month, day, year); (8) Date of device explantation (month, day, year); (9) Whether device was available for evaluation and whether device was returned to the manufacturer; if so, the date it was returned to the manufacturer; and (10) Concomitant medical products and therapy dates. (Do not list products that were used to treat the event.) (d) Initial reporter information (Block E) shall contain the following: (1) Name, address, and telephone number of the reporter who initially provided information to the user facility, manufacturer, or distributor; (2) Whether the initial reporter is a health professional; (3) Occupation; and (4) Whether initial reporter also sent a copy of the report to FDA, if known. (e) User facility information (Block F) shall contain the following: (1) Whether reporter is a user facility; (2) User facility number; (3) User facility address; (4) Contact person; (5) Contact person's telephone number; (6) Date the user facility became aware of the event (month, day, year); (7) Type of report (initial or followup (if followup, include report number of initial report)); (8) Date of the user facility report (month, day, year); (9) Approximate age of device; (10) Event problem codes--patient code and device code (refer to FDA ``Coding Manual For Form 3500A''); (11) Whether a report was sent to FDA and the date it was sent (month, day, year); (12) Location, where event occurred; (13) Whether report was sent to the manufacturer and the date it was sent (month, day, year); and (14) Manufacturer name and address; if available. Sec. 803.33 Semiannual reports. (a) Each user facility shall submit to FDA a semiannual report on FDA Form 3419, or electronic equivalent as approved by FDA under Sec. 803.14. Semiannual reports shall be submitted by January 1 (for reports made July through December) and by July 1 (for reports made January through June) of each year. The semiannual report and envelope shall be clearly identified and submitted to FDA with information that includes: (1) User facility's HCFA provider number used for medical device reports, or number assigned by FDA for reporting purposes in accordance with Sec. 803.3(dd); (2) Reporting year and period, e.g., January through June or July through December; (3) Facility's name and complete address; (4) Total number of reports attached or summarized; (5) Date of the semiannual report and the lowest and highest user facility report number of medical device reports submitted during the report period, e.g., 1234567890-1995-0001 through 1000; (6) Name, position title, and complete address of the individual designated as the facility contact person responsible for reporting to FDA and whether that person is a new contact for that facility; and (7) Information for each reportable event that occurred during the semiannual reporting period including: (i) User facility report number; (ii) Name and address of the device manufacturer; (iii) Device brand name and common name; (iv) Product model, catalog, serial and lot number; (v) A brief description of the event reported to the manufacturer and/or FDA; and (vi) Where the report was submitted, i.e., to FDA, manufacturer, distributor, etc. (b) In lieu of submitting the information in paragraph (a)(7) of this section, a user facility may submit a copy of FDA Form 3500A, or an electronic equivalent as approved under section 803.14, for each medical device report submitted to FDA and/or [[Page 63604]] manufacturers by that facility during the reporting period. (c) If no reports are submitted to either FDA or manufacturers during these time periods, no semiannual report is required. Subpart D--[Reserved] Subpart E--Manufacturer Reporting Requirements Sec. 803.50 Individual adverse event reports; manufacturers. (a) Reporting standards. Device manufacturers are required to report within 30 days whenever the manufacturer receives or otherwise becomes aware of information, from any source, that reasonably suggests that a device marketed by the manufacturer: (1) May have caused or contributed to a death or serious injury; or (2) Has malfunctioned and such device or similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. (b) Information that is reasonably known to manufacturers.--(1) Manufacturers must provide all information required in this subpart E that is reasonably known to them. FDA considers the following information to be reasonably known to the manufacturer: (i) Any information that can be obtained by contacting a user facility, distributor and/or other initial reporter; (ii) Any information in a manufacturer's possession; or (iii) Any information that can be obtained by analysis, testing or other evaluation of the device. (2) Manufacturers are responsible for obtaining and providing FDA with information that is incomplete or missing from reports submitted by user facilities, distributors, and other initial reporters. Manufacturers are also responsible for conducting an investigation of each event, and evaluating the cause of the event. If a manufacturer cannot provide complete information on an MDR report, it must provide a statement explaining why such information was incomplete and the steps taken to obtain the information. Any required information not available at the time of the report, which is obtained after the initial filing, must be provided by the manufacturer in a supplemental report under Sec. 803.56. Sec. 803.52 Individual adverse event report data elements. Individual medical device manufacturer reports shall contain the following information, known or reasonably known to them as described in Sec. 803.50(b), which corresponds to the format of FDA Form 3500A: (a) Patient information (Block A) shall contain the following: (1) Patient name or other identifier; (2) Patient age at the time of event, or date of birth; (3) Patient gender; and (4) Patient weight. (b) Adverse event or product problem (Block B) shall contain the following: (1) Adverse event or product problem; (2) Outcomes attributed to the adverse event, e.g., death; or serious injury, that is: (i) Life threatening injury or illness; (ii) Disability resulting in permanent impairment of a body function or permanent damage to a body structure; or (iii) Injury or illness that requires intervention to prevent permanent impairment of a body structure or function; (3) Date of event; (4) Date of report by the initial reporter; (5) Description of the event or problem to include a discussion of how the device was involved, nature of the problem, patient followup or required treatment, and any environmental conditions that may have influenced the event; (6) Description of relevant tests, including dates and laboratory data; and (7) Other relevant patient history including pre-existing medical conditions. (c) Device information (Block D) shall contain the following: (1) Brand name; (2) Type of device; (3) Manufacturer name and address; (4) Operator of the device (health professional, patient, lay user, other); (5) Expiration date; (6) Model number, catalog number, serial number, lot number or other identifying number; (7) Date of device implantation (month, day, year); (8) Date of device explantation (month, day, year); (9) Whether the device was available for evaluation, and whether the device was returned to the manufacturer, and if so, the date it was returned to the manufacturer; and (10) Concomitant medical products and therapy dates. (Do not list products that were used to treat the event.) (d) Initial reporter information (Block E) shall contain the following: (1) Name, address, and phone number of the reporter who initially provided information to the user facility, manufacturer, or distributor; (2) Whether the initial reporter is a health professional; (3) Occupation; and (4) Whether the initial reporter also sent a copy of the report to FDA, if known. (e) All manufacturers (Block G) shall contain the following: (1) Contact office name and address and device manufacturing site; (2) Telephone number; (3) Report sources; (4) Date received by manufacturer (month, day, year); (5) Type of report being submitted (e.g., 5-day, initial, supplemental); and (6) Manufacturer report number. (f) Device manufacturers (Block H) shall contain the following: (1) Type of reportable event (death, serious injury, malfunction, etc.); (2) Type of followup report, if applicable (e.g., correction, response to FDA request, etc.); (3) If the device was returned to the manufacturer and evaluated by the manufacturer, a summary of the evaluation. If no evaluation was performed, provide an explanation why no evaluation was performed; (4) Device manufacture date (month, day, year); (5) Was device labeled for single use; (6) Evaluation codes (including event codes, method of evaluation, result, and conclusion codes) (refer to FDA ``Coding Manual for Form 3500A''); (7) Whether remedial action was taken and type; (8) Whether use of device was initial, reuse, or unknown; (9) Whether remedial action was reported as a removal or correction under section 519(f) of the act (list the correction/removal report number); and (10) Additional manufacturer narrative; and/or (11) Corrected data, including: (i) Any information missing on the user facility report or distributor report, including missing event codes, or information corrected on such forms after manufacturer verification; (ii) For each event code provided by the user facility under Sec. 803.32(d)(10) or a distributor, a statement of whether the type of the event represented by the code is addressed in the device labeling; and (iii) If any required information was not provided, an explanation of why such information was not provided and the steps taken to obtain such information. Sec. 803.53 Five-day reports. A manufacturer shall submit a 5-day report to FDA, on Form 3500A or electronic equivalent as approved by FDA under Sec. 803.14 within 5 workdays of: [[Page 63605]] (a) Becoming aware that a reportable MDR event or events, from any information, including any trend analysis, necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health; or (b) Becoming aware of an MDR reportable event for which FDA has made a written request for the submission of a 5-day report. When such a request is made, the manufacturer shall submit, without further requests, a 5-day report for all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request. The time period stated in the original written request can be extended by FDA if it is in the interest of the public health. Sec. 803.55 Baseline reports. (a) A manufacturer shall submit a baseline report on FDA Form 3417, or electronic equivalent as approved by FDA under Sec. 803.14 for a device when the device model is first reported under Sec. 803.50. (b) Each baseline report shall be updated annually, on the anniversary month of the initial submission, after the initial baseline report is submitted. Changes to baseline information shall be reported in the manner described in Sec. 803.56 (i.e., include only the new, changed, or corrected information in the appropriate portion(s) of the report form). Baseline reports shall contain the following: (1) Name, complete address, and registration number of the manufacturer's reporting site. If the reporting site is not registered, FDA will assign a temporary registration number until the reporting site officially registers. The manufacturer will be informed of the temporary registration number; (2) FDA registration number of each site where the device is manufactured; (3) Name, complete address, and telephone number of the individual who has been designated by the manufacturer as its MDR contact and date of the report. For foreign manufacturers, a confirmation that the individual submitting the report is the agent of the manufacturer designated under Sec. 803.58(a) is required; (4) Product identification, including device family, brand name, generic name, model number, catalog number, product code and any other product identification number or designation; (5) Identification of any device previously reported in a baseline report that is substantially similar (e.g., same device with a different model number, or same device except for cosmetic differences in color or shape) to the device being reported, including the identification of the previously reported device by model number, catalog number or other product identification, and the date of the baseline report for the previously reported device; (6) Basis for marketing, including 510(k) premarket notification number or PMA number, if applicable, and whether the device is currently the subject of an approved post-market study under section 522 of the act; (7) Date the device was initially marketed and, if applicable, the date on which the manufacturer ceased marketing the device; (8) Shelf life, if applicable, and expected life of the device; (9) The number of devices manufactured and distributed in the last 12 months and, an estimate of the number of devices in current use; and (10) Brief description of any methods used to estimate the number of devices distributed and the method used to estimate the number of devices in current use. If this information was provided in a previous baseline report, in lieu of resubmitting the information, it may be referenced by providing the date and product identification for the previous baseline report. Sec. 803.56 Supplemental reports. When a manufacturer obtains information required under this part that was not provided because it was not known or was not available when the initial report was submitted, the manufacturer shall submit to FDA the supplemental information within 1 month following receipt of such information. In supplemental reports, the manufacturer shall: (a) Indicate on the form and the envelope, that the reporting form being submitted is a supplemental report. If the report being supplemented is an FDA Form 3500A report, the manufacturer must select, in Item H-2, the appropriate code for the type of supplemental information being submitted; (b) Provide the appropriate identification numbers of the report that will be updated with the supplemental information, e.g., original manufacturer report number and user facility report number, if applicable; (c) For reports that cross reference previous reports, include only the new, changed, or corrected information in the appropriate portion(s) of the respective form(s). Sec. 803.57 Annual certification. All manufacturers, including U.S. agents of foreign manufacturers required to report under this section, shall submit a certification report to FDA, on FDA Form 3381, or electronic equivalent as approved under part 814 of this chapter. The date for submission of certification coincides with the date for the firm's annual registration, as designated in Sec. 807.21 of this chapter. The certification period will be the 12-month period ending 1 month before the certification date. The reports shall contain the following information: (a) Name, address, telephone number, and FDA registration number or FDA-assigned identification number of the firm and whether the firm is a manufacturer; (b) A statement certifying that: (1) The firm listed in paragraph (a) of this section has filed reports for all reportable events required under this section during the previous 12-month period. The firm shall also provide a numerical summary of MDR reports that it submitted to FDA during the preceding year; or (2) The firm listed in paragraph (a) of this section did not receive reportable events for any devices manufactured by the firm during the previous 12-month period. (c) Certification shall be made by the president, chief executive officer, U.S.-designated agent of a foreign manufacturer, or other official most directly responsible for the firm's operations; and (d) Name of the manufacturer and registration numbers submitted under paragraph (a) of this section shall be the same as those used in submitting the reports required by Secs. 803.52, 803.53 and 803.55. Multisite manufacturers who choose to certify centrally must identify the reporting sites, by registration number or FDA-assigned identification number and name covered by the certification, and provide the information required by paragraph (b) of this section for each reporting site. Sec. 803.58 Foreign manufacturers. (a) Every foreign manufacturer whose devices are distributed in the United States shall designate a U.S. agent to be responsible for reporting in accordance with Sec. 807.40 of this chapter. The U.S. designated agent accepts responsibility for the duties that such designation entails. Upon the effective date of this regulation, foreign manufacturers shall inform FDA, by letter, of the name and address of the U.S. agent designated under this section and Sec. 807.40 of this chapter, and shall update this information as necessary. Such updated information shall be submitted to FDA, within 5 days of a change in the designated agent information. [[Page 63606]] (b) U.S.-designated agents of foreign manufacturers are required to: (1) Report to FDA in accordance with Secs. 803.50, 803.52, 803.53, 803.55, and 803.56; (2) Conduct, or obtain from the foreign manufacturer the necessary information regarding, the investigation and evaluation of the event to comport with the requirements of Sec. 803.50; (3) Certify in accordance with Sec. 803.57; (4) Forward MDR complaints to the foreign manufacturer and maintain documentation of this requirement; (5) Maintain complaint files in accordance with Sec. 803.18; and (6) Register, list, and submit premarket notifications in accordance with part 807 of this chapter. PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND DISTRIBUTORS OF DEVICES 2. The authority citation for 21 CFR part 807 continues to read as follows: Authority: Secs. 301, 501, 502, 510, 513, 515, 519, 520, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 351, 352, 360, 360c, 360e, 360i, 360j, 371, 374). 3. Section 807.3 is amended by adding new paragraph (r) to read as follows: Sec. 807.3 Definitions. * * * * * (r) U.S.-designated agent means the person, residing in the United States, designated and authorized by the owner or operator of a foreign manufacturer who exports devices into the United States and is responsible for: (1) Submitting MDR reports, (2) Submitting annual certifications, (3) Acting as the official correspondent, (4) Submitting registration information, (5) Submitting device listing information, and (6) Submitting premarket notifications on behalf of the foreign manufacturer. 4. Section 807.20 is amended by adding new paragraph (a)(6) to read as follows: Sec. 807.20 Who must register and submit a device list. (a) * * * (6) Acts as the U.S.-designated agent as defined in Sec. 807.3(r). * * * * * 5. Section 807.22 is amended by revising paragraph (a) to read as follows: Sec. 807.22 How and where to register establishments and list devices. (a) The first registration of a device establishment shall be on Form FDA-2891 (Initial Registration of Device Establishment). Forms are available upon request from the Office of Compliance, Center for Devices and Radiological Health (HFZ-307), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, or from Food and Drug Administration district offices. Subsequent annual registration shall be accomplished on Form FDD-2891a (Annual Registration of Device Establishment), which will be furnished by FDA to establishments whose registration for that year was validated under Sec. 807.35(a). The forms will be mailed to the owner or operators of all establishments via the official correspondent in accordance with the schedule as described in Sec. 807.21(a). The completed form shall be mailed to the address designated in this paragraph 30 days after receipt from FDA. * * * * * 6. Section 807.40 is revised to read as follows: Sec. 807.40 Establishment registration and device listing for U.S. agents of foreign manufacturers of devices. (a) Each foreign device manufacturer who exports devices into the United States shall designate a person as their U.S.-designated agent, who is responsible for: (1) Submitting MDR reports, (2) Submitting annual certifications, (3) Acting as the official correspondent, (4) Submitting registration information, (5) Submitting device listing information, and (6) Submitting premarket notifications. (b) The foreign manufacturer shall provide FDA with a statement of authorization for their U.S.-designate to perform MDR reporting duties under part 803 of this chapter, and to register, list, and submit premarket notifications under this part. The foreign manufacturer must provide this statement of authorization along with the name, address, and telephone number of the person initially designated, or any subsequent person designated as the U.S.-designated agent, within 5 days of the initial or subsequent designation. Information shall be sent to the Center for Devices and Radiological Health, Medical Device Reporting, Food and Drug Administration, P.O. Box 3002, Rockville, MD 20847-3002. (c) The U.S.-designated agent of a foreign device manufacturer that exports devices into the United States is required to register the foreign manufacturer's establishments or places of business, and to list the foreign manufacturer's devices, in accordance with subpart B of this part, unless exempt under subpart D of this part, and to submit premarket notifications in accordance with subpart E of this part. The information submitted shall be in the English language. Dated: October 25, 1995. William B. Schultz, Deputy Commissioner for Policy. [FR Doc. 95-29906 Filed 12-8-95; 8:45 am] BILLING CODE 4160-01-P